Job Summary:

• Oversight and management of the eTMF
• Organising and maintaining the TMFs
• Collation of documents from monitors and/or CROs
• Assist in setting up clinical study files
• Create drafts of study specific documents.
• Seek signatures for approved documents.
• Support Clinical Project Managers
• Arranging cross-functional meetings and distributing minutes
• Assist with the tracking of project timelines
• Maintain budget tracking tools when required

Skills on Resume:

• eTMF Management (Hard Skills)
• TMF Organization (Hard Skills)
• Document Collation (Hard Skills)
• File Setup (Hard Skills)
• Document Drafting (Hard Skills)
• Signature Collection (Soft Skills)
• Project Manager Support (Soft Skills)
• Meeting Arrangement (Soft Skills)

Job Summary:

• Responsible for the conduct of the following activities with general instruction and guidance
• Assists in contacting investigator sites to provide study specific information
• Ensures receipt, completeness and accuracy of clinical and administrative documents
• Coordinates distribution and shipment of study-related materials
• Coordinates investigator site/payments
• Coordinates vendor payments (including tracking of invoices and payments)
• Assists CPM/designee with contract and budget management
• Maintains telephone contact list of sites, Contract Research Organization (CRO) personnel, vendors and CRAs 
• Facilitates flow and maintenance of correspondence with sites on behalf of the CPM/designee
• Attends clinical project team meetings, takes minutes and tracks action items to resolution
• Assists in coordination of study initiation documentation materials

Skills on Resume:

• Effective Communication (Soft Skills)
• Document Accuracy (Hard Skills)
• Logistics Coordination (Hard Skills)
• Payment Tracking (Hard Skills)
• Contract Management (Hard Skills)
• Administrative Support (Soft Skills)
• Meeting Coordination (Soft Skills)
• Study Initiation (Hard Skills)

Job Summary:

• Assists in the tracking of study team and site personnel training activities, as relevant
• Performs administrative and clerical duties. 
• Assists in the use of DocuSign to enable electronic approval of documentation
• Coordinates distribution of study team materials and meeting minutes
• Drafts and prepares documents for mass mailings (e.g., protocol amendments)
• Assists with preparation of presentation materials
• Maintains central registry of contact information for clinical sites, CROs, vendors and CRAs.
• Sets up teleconference calls with sites and team when required and records meeting minutes
• Create and maintains Central Clinical files
• Maintains scentral monitoring calendar for all site visits
• Liaises with Clinical Research Associate (CRAs) regarding reconciliation activities between the Trial Master File (TMF) and Investigator Site File (ISF)

Skills on Resume:

• Training Tracking (Hard Skills)
• Clerical Duties (Hard Skills)
• DocuSign Utilization (Hard Skills)
• Materials Coordination (Hard Skills)
• Document Drafting (Hard Skills)
• Presentation Preparation (Hard Skills)
• Contact Registry Maintenance (Hard Skills)
• Teleconference Setup (Soft Skills)

Job Summary:

• Facilitate the creation of study specific TMF management tools
• Maintain TMF Management Plans and TMF Content Lists
• Work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
• Coordinate creation of the TMF filing locations within InCarda based on the study specific TMF Content List
• Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
• Facilitate the review and submission of TMF records
• Support the coordination of the transfer of study-specific trial master files from the CRO
• Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
• Support Study Teams in understanding their TMF-related responsibilities, requirements and expectations
• Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to InCarda processes

Skills on Resume:

• TMF Tool Creation (Hard Skills)
• TMF Plan Maintenance (Hard Skills)
• Plan Verification (Soft Skills)
• TMF Location Setup (Hard Skills)
• Document Quality Control (Hard Skills)
• TMF Record Review (Hard Skills)
• File Transfer Coordination (Hard Skills)
• TMF Support (Soft Skills)

Job Summary:

• Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
• Manage the TMF content list and TMF Comprehensive Review tracker
• Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study specific TMF Plan
• Identify any corrective actions which must be addressed and assigned
• Support the management of TMF documentation issues throughout the lifecycle of an assigned study Records Management
• Participate in the implementation of standards and processes for records management to verify compliance with relevant regulations
• Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records
• Process records (e.g., track, scan, archive) in compliance with InCarda SOPs and study specific TMF Plans
• Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records
• Provide guidance on best practices for record handling, retrieval and archival procedures

Skills on Resume:

• Audit Support (Hard Skills)
• Content Management (Hard Skills)
• Quality Review (Hard Skills)
• Action Identification (Soft Skills)
• Issue Management (Hard Skills)
• Records Compliance (Hard Skills)
• Record Processing (Hard Skills)
• Training Prep (Soft Skills)

Job Summary:

• Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
• Participate in the development, implementation, and maintenance of internal databases used to manage records
• Assist in the preparation of project and study-related documents including informed consent forms, pharmacy manual, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries
• Assist with coordination of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IV(W)RS specification process and user acceptance testing
• Assist in monitoring and tracking clinical trial progress and providing status update reports and study metrics
• Assist in the planning of investigator meetings and making presentations, as required.
• Prepare meeting agendas and minutes
• Facilitate communications on behalf of the Study Team to include correspondence, mass mailings, email communications, etc. 
• Assist in the review of clinical data in the CRF, data listing, and report table levels

Skills on Resume:

• Document Provision (Hard Skills)
• Database Management (Hard Skills)
• Document Preparation (Hard Skills)
• CRF Coordination (Hard Skills)
• Trial Monitoring (Hard Skills)
• Meeting Planning (Soft Skills)
• Agenda Preparation (Soft Skills)
• Communication Facilitation (Soft Skills)

Job Summary:

• Assists with in-house reconciliation of IWRS queries to ensure compliance with case report forms (EDC), protocol, pharmacy manual and standard operating procedures (SOPs).
• Recommends sites for oversight visits based on pre-specified criteria (i.e., repeat major deviations, failure to perform drug accountability appropriately, etc.)
• Manages the collection, review, and approval of regulatory and essential documents from clinical sites
• Manages the submission of protocols, amendments, subject facing documents to Central IRB for review and approval for U.S. sites and follows up on or coordinates responses to IRB questions and queries
• Interfaces with site coordinators, field clinical staff, CROs and other company representatives
• Is actively involved in the performance of study feasibility assessments
• Coordinates investigational product release activities across clinical sites
• Responsible for ordering study binders, inserts and assembly for Zogenix conducted studies
• Responsible for ordering and shipping specified supplies for clinical studies and maintains inventories

Skills on Resume:

• IWRS Reconciliation (Hard Skills)
• Site Oversight (Soft Skills)
• Document Management (Hard Skills)
• Protocol Submission (Hard Skills)
• Site Coordination (Soft Skills)
• Feasibility Assessment (Hard Skills)
• Product Release (Hard Skills)
• Supply Management (Hard Skills)

Job Summary:

• Develop TMF plans and QC plans as necessary for studies
• Develop document packages for sites and review regulatory documents for completeness during study start-up
• Develop and manage various study trackers
• Prepare, assemble and distribute site regulatory binders and other study specific manuals
• Prepare and distribute meeting agendas/minutes
• Coordinate the distribution of documents to the sites/monitors and vendors
• Facilitate purchase orders and track clinical supply inventory
• Responsible for maintaining and communicating project updates via study trackers
• Responsible for collecting, tracking and archiving Essential Documents including financial disclosure forms at the end of the study and one year after study end. 
• Notify sites/CRO of missing documents or documents that need updating.
• Provide appropriate site documents to Regulatory (1572’s, CVs, and Financial Disclosure documents)
• May attend Investigator Meetings and/or support meeting planning with vendor

Skills on Resume:

• TMF Plan Development (Hard Skills)
• Document Packages (Hard Skills)
• Study Trackers (Hard Skills)
• Binder Preparation (Hard Skills)
• Agenda Preparation (Soft Skills)
• Document Distribution (Hard Skills)
• Supply Inventory (Hard Skills)
• Essential Document Tracking (Hard Skills)

Job Summary:

• Facilitating role in multiple clinical trials in order to start-up trial sites according the timelines while ensuring high-quality
• Administrative management of trials
• Performing multiple in-house CRA tasks during the trial being the central partner for the trial team, related associates, study sites, the clinical trial team, and all vendors
• Facilitating and participating in trial team meetings
• Applying company policies and procedures to resolve routine issues
• Continuously collaborating with the other associates and team members.
• Assists in the preparation of Investigator and Study Coordinator Meetings
• Maintains tracking systems and reports study metrics to support the clinical trial programs
• Responsible for study-specific training of Clinical Research Assistants
• Responsible for assigning site numbers

Skills on Resume:

• Trial Facilitation (Soft Skills)
• Administrative Management (Hard Skills)
• In-House CRA Tasks (Hard Skills)
• Meeting Participation (Soft Skills)
• Issue Resolution (Soft Skills)
• Team Collaboration (Soft Skills)
• Meeting Preparation (Hard Skills)
• Training and Metrics (Hard Skills)

Job Summary:

• Assist with formatting/production and distribution of key study documents such as investigator brochures, protocols, informed consent forms, interim safety reports, and site educational and reference material
• Assist project team with study specific documentation including filing to the Clinical Trial Management System and Trial Master File
• Maintain Trial Master File by setting up and using tracking tools
• Assist with investigator recruitment by making initial site contact, obtaining confidentiality agreements, forwarding study synopsis to sites and administering feasibility questionnaires
• Assist project team with gathering agenda topics, preparing agenda, scheduling meetings, attend and generate project meeting minutes
• Facilitate submission of regulatory documents to/for a central institutional review board (IRB) and coordinate collection, tracking, and maintenance of updated site regulatory documentation
• Participate in organizing investigator meetings including venue investigation, selection, invitations, agenda and materials distribution
• Track clinical supply inventory at sites and manage the site drug re-supply process
• Set-up and maintain tracking system with oversight of manager
• Develop working knowledge of company standard operating procedures (SOPs) and FDA regulations related to clinical studies
• Provide general administrative support to the Clinical Operations Department

Skills on Resume:

• Document Production (Hard Skills)
• Documentation Filing (Hard Skills)
• TMF Maintenance (Hard Skills)
• Investigator Recruitment (Soft Skills)
• Meeting Coordination (Soft Skills)
• Regulatory Submission (Hard Skills)
• Supply Tracking (Hard Skills)
• Administrative Support (Soft Skills)

Job Summary:

• Administrative tasks within the framework of a project
• Support the clinical trial project team with tasks such as general logistics support
• Administrative support to study specific subject visits, and related documents
• Ordering of study related meals
• Source documents and Investigator File filing and archiving
• Preparation of study specific binders
• Support during monitoring visits
• Create lab request forms, follow up on lab results
• Ensure completion of study specific Case Report Forms (CRF) by
• Completing and correcting source data, where applicable
• Manual source data entry in paper CRF where applicable
• Electronic source data-entry in SGS or sponsor Electronic Data Capture systems
• Attend and contributes to team and staff meetings
• Provide on a weekly basis all job-related time and labor progress reports 

Skills on Resume:

• Administrative Tasks (Soft Skills)
• Logistics Support (Hard Skills)
• Visit Support (Soft Skills)
• Meal Ordering (Hard Skills)
• Document Filing (Hard Skills)
• Binder Preparation (Hard Skills)
• Monitoring Support (Soft Skills)
• Data Entry (Hard Skills)

Job Summary:

• Manage various aspects of day-to-day operations of clinical trials as assigned. 
• Provide general support to the Clinical Trial Manager (CTM) and field Clinical Research Associates (CRAs) to manage the investigator sites and ensure compliance. 
• Manage the collection, review and tracking of essential regulatory documents in support of new clinical study site activation. 
• Manage and serve as a point of contact for contract research organizations (CROs) and third-party vendors
• Identifying potential risks and proactively resolving issues that arise. 
• Ensure all clinical sites are provisioned with appropriate ancillary supplies, investigational product, and associated documentation by establishing purchase orders, processing orders, and arranging for delivery by vendors and/or internal departments as necessary. 
• Collect and process clinical site surgical notification forms
• Add surgical procedures to calendar from study-specific distribution list.   
• Manage all investigational product (IP) requests, including, but not limited to: IP manufacturing requests, tracking of all IP shipping and delivery, IP accountability logs, and inventory reports.    
• Create explant plans for review by CTM, send plan to clinical site and update internal calendar 

Skills on Resume:

• Operations Management (Hard Skills)
• Team Support (Soft Skills)
• Regulatory Document Management (Hard Skills)
• Vendor Coordination (Soft Skills)
• Risk Identification (Soft Skills)
• Supply Provisioning (Hard Skills)
• Surgical Notification Processing (Hard Skills)
• IP Management (Hard Skills)

Job Summary:

• Upload study procedure surgical photos and videos to local drives. 
• Establish templates within electronic Trial Master File (eTMF) system. 
• Collect and process electronic case report form (eCRF) access requests from clinical sites and internal team members. 
• Assist in the development of reports for communicating study progress and key metrics to the management team. 
• As needed, travel to investigator sites and perform site monitoring, reviewing source documents, CRF entries, regulatory files, IP accountability records, and all other relevant study documents to ensure site compliance and data validity. 
• Schedule & set up necessary tele- or videoconferencing meeting requirements (i.e., GoToMeeting, Webex, etc.) for Clinical Development team as needed. 
• Capture and file minutes for in-house meetings and conference calls with CROs, vendors, and cross-functional teams.   
• Review and update Standard Operating Procedures (SOPs). 
• Maintain effective communication with study teams throughout study cycle. 
• Complete other study-related tasks as required by Clinical Development Team members. 

Skills on Resume:

• Media Uploads (Hard Skills)
• eTMF Templates (Hard Skills)
• eCRF Access Management (Hard Skills)
• Report Development (Hard Skills)
• Site Monitoring (Hard Skills)
• Meeting Setup (Soft Skills)
• Minute Taking (Soft Skills)
• SOP Review (Hard Skills)

Job Summary:

• Conducts study tracking support (eg. CTMS, study start up metrics and milestones, patient enrolment, drug shipments etc)
• Assists with in-house reconciliation of IWRS queries to ensure compliance with case report forms (EDC), protocol, pharmacy manual and Standard Operating Procedures (SOPs).
• Assists in identifying sites for oversight visits based on pre-specified criteria (i.e., repeat major deviations, failure to perform drug accountability appropriately, etc.
• Manages the collection, review, and approval of regulatory and essential documents from clinical sites
• May have some responsibility for ordering and shipping supplies in coordination with all phases of the clinical studies, maintains files and inventories of chemicals, supplies and equipment.
• Assists with the submission of protocols, amendments, subject facing documents to Independent Ethics Committees/Institutional Review Boards (IRBs) and coordinates responses to queries
• Performs document tracking and signature/approval follow-up where applicable eg Confidential Disclosure Agreements, contracts, payments, invoices and other study documentation
• May be responsible for timely study entry and updates to CT.Gov and other competent authority platforms
• Manages and maintains the TMF and assists the Study Lead in QC- related activities
• Interfaces with site coordinators, field clinical staff, CROs and other company representatives

Skills on Resume:

• Study Tracking (Hard Skills)
• IWRS Reconciliation (Hard Skills)
• Site Identification (Soft Skills)
• Document Management (Hard Skills)
• Supply Coordination (Hard Skills)
• Protocol Submission (Hard Skills)
• Document Tracking (Hard Skills)
• TMF Maintenance (Hard Skills)

Job Summary:

• May assist in the performance of study feasibility assessments
• In collaboration with Clinical Supply, Regulatory, coordinates investigational product release activities across clinical sites ensuring proper drug shipments and returns and assisting where necessary with in-house reconciliation
• Assists in the meeting coordination and facilitation as well as the preparation of Investigator and Study Coordinator Meetings
• Maintains clinical operations files, databases and tracking systems and reports study metrics to support the clinical trial programs
• Participates in and presents status updates in project team meetings
• Assists in User Acceptance Testing for various clinical systems
• Responsible for maintaining and coordinating the logistical aspects of clinical trials according to Good Clinical Practices (GCP) and relevant SOPs
• Ensure regulatory compliance of Trial Master File (TMF) components for clinical research studies
• Support implementation of technology enabled processes and will develop effective and productive partnerships with teams and other groups to ensure deliverables meet project goals and objectives

Skills on Resume:

• Feasibility Assessment (Soft Skills)
• Product Coordination (Hard Skills)
• Meeting Support (Soft Skills)
• File Maintenance (Hard Skills)
• Status Updates (Soft Skills)
• System Testing (Hard Skills)
• Logistics Management (Hard Skills)
• TMF Compliance (Hard Skills)

Job Summary:

• Provide day to day departmental/project support activities
• Coordinate and provide minutes for departmental and organization wide meetings/conference calls
• Partner with department to process expense reports in an accurate and timely manner
• Aid department staff by managing schedule(s) and handling a wide variety of administrative functions
• Ensure that requests for action or information are appropriately routed
• Contact or respond to contacts from high ranking internal and external individuals
• Maintain database/spreadsheets as necessary to facilitate tracking/documentation of activities
• Conduct quality control reviews of documents 
• Develop understanding of appropriate SOPs and policies
• Assist with preparation of final contract documentation, liaising with study teams and study centers
• Perform administrative tasks as needed to support successful contract negotiation/execution.

Skills on Resume:

• Project Support (Soft Skills)
• Meeting Coordination (Soft Skills)
• Expense Processing (Hard Skills)
• Schedule Management (Soft Skills)
• Request Routing (Soft Skills)
• High-Level Communication (Soft Skills)
• Database Maintenance (Hard Skills)
• Document QC (Hard Skills)

Job Summary:

• Supports the execution of clinical studies
• Responsible for study start up activities
• Tracks study related documents
• Manages logistics and document exchange between clinical sites and company
• Managing the setting up and maintaining of Trial Master Files
• Managing the setting up of Investigator Site files and study set-up documentation for assigned studies
• Prepare and collect study documentation in conjunction with Clinical Study Managers, Senior / Clinical Research Associate prior to study set-up and maintain collection of documentation during study
• Assist with receipt and shipping of study documentation to Investigator sites, maintain internal trackers
• Assist Project team with internal filing processes for assigned studies
• Responsible for organising and participating in project/study team and functional group meetings

Skills on Resume:

• Study Execution (Hard Skills)
• Start-Up Activities (Hard Skills)
• Document Tracking (Hard Skills)
• Logistics Management (Hard Skills)
• TMF Management (Hard Skills)
• Site File Setup (Hard Skills)
• Documentation Preparation (Hard Skills)
• Meeting Organization (Soft Skills)

Job Summary:

• Deeply acknowledges and strictly follows Excelya and sponsors’ SOPs, guidelines and appropriate local and international legislation
• Keeps himself/herself continuously informed with regards to any amendments or updates of the national submission requirements and procedures
• Collects all necessary information and documents for the preparation of the clinical trial application and compiles the file for submission
• Ensures the correct implementation of the application to the IRBs/IECs, National EC and Regulatory Authorities as well as the approval procedure by these bodies following up and tracking any necessary actions
• Tracks and updates the contact details of National EC, Regulatory Authorities and YPE/ELKE
• Tracks and updates country specific requirements regarding ICFs, insurance requirements etc
• Prepares the contract between the sponsor and the Investigators or the external vendors (when applicable) and follows up the contract execution
• Handles the financial issues of the study, including investigator payments, regulatory fees, according to the appropriate financial agreements and documents
• Performs the adaptation of informed consent as per national requirements
• Ensures all relevant trackers and Excelya Sharepoint libraries are kept appropriately up-to-date as required for each project

Skills on Resume:

• SOP Compliance (Hard Skills)
• Regulatory Updates (Soft Skills)
• Application Preparation (Hard Skills)
• Submission Management (Hard Skills)
• Contact Tracking (Soft Skills)
• Requirement Updates (Hard Skills)
• Contract Preparation (Hard Skills)
• Financial Handling (Hard Skills)

Job Summary:

• Prepares and negotiates the budgets and contracts with investigators and the relevant authorities
• Is responsible for reimbursement of laboratory examinations and assessments to the Hospitals
• Collects required documents from sites e.g. CVs, IEC approvals, Signed Application Forms and keeps trackers up-to-date
• Collects the initial package of essential documents required for drug shipment
• Prepares and sends Investigator Site Files
• Provides to sponsor or uploads directly all required documents in client/sponsor platform or TMF
• Follows up on any TMF issues and ensures resolution within timelines
• Assists project teams in the shipment of SUSARs and other regulatory documents to IRBs and Regulatory Authorities
• Coordinates translation of documents to local language through approved vendors
• Participates to the project team meetings
• May undertake other tasks as they may be assigned from the supervisor that will concern Excelya

Skills on Resume:

• Budget Negotiation (Hard Skills)
• Reimbursement Management (Hard Skills)
• Document Collection (Hard Skills)
• Drug Shipment Preparation (Hard Skills)
• Site File Preparation (Hard Skills)
• Document Uploading (Hard Skills)
• TMF Issue Resolution (Hard Skills)
• Document Translation (Soft Skills)

Job Summary:

• Supporting and collaborating with the clinical trial personnel in various administrative tasks (including Project Managers and CRAs)
• Compiling information for submissions to ethics committee
• Executing administration of clinical studies such as invoices and payments
• Administrative, practical and document management, tracking and review
• Actively contributes to results oriented department goals
• Drives continuous improvement of GSO
• Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
• Updates Clinical Study Management Systems

Skills on Resume:

• Administrative Support (Soft Skills)
• Submission Compilation (Hard Skills)
• Invoice Management (Hard Skills)
• Document Management (Hard Skills)
• Goal Contribution (Soft Skills)
• Process Improvement (Soft Skills)
• Best Practice Identification (Soft Skills)
• System Updates (Hard Skills)

Job Summary:

• Schedule study related meetings (e.g. client, internal, vendor and investigator meetings).
• Assist with the preparation of agenda and lead the creation of meeting minutes, and action item tracking and follow up.
• Lead the documentation, reviewing, distribution and filing of study related meeting minutes.
• Initiate and maintain study mailbox, including access requests or routing correspondence for project and any departmental Functional Leads.
• Manage study systems access requests (e.g. SharePoint, CTMS, eTMF system, study mailboxes)
• Maintain specified sections within CTMS (e.g. study team lists, SOP lists, FAQ lists)
• Assemble and ship Investigator Site File binders to study sites.
• Create study surveys using designated study tool.
• Responsible for accurate distribution and tracking of non-investigational product to study sites.
• May also include submitting orders for non-investigational study supplies.

Skills on Resume:

• Meeting Coordination (Soft Skills)
• Document Management (Hard Skills)
• Communication (Soft Skills)
• System Access Management (Hard Skills)
• Database Maintenance (Hard Skills)
• Logistics Coordination (Hard Skills)
• Survey Creation (Hard Skills)
• Attention to Detail (Soft Skills)

Job Summary:

• Provide day-to-day Training & Development (T&D) support activities
• Maintenance of T&D files, disseminating training reminders, etc
• Perform administrative duties in conformity with company policies and procedures
• Schedule training session, coordinate & schedule departmental and individual training meetings 
• Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities
• Conduct quality control reviews of departmental documents
• Support other departments on ad hoc projects
• Perform other administrative tasks 
• Assist with the creation and distribution of study newsletters.
• Responsible for requesting, tracking and documentation of project specific training.
• Act as a mentor and help in training/ onboarding of new Clinical Trial Assistants.
• Support the Project Manager in the filing of study level documents into the eTMF, in addition to other eTMF related support the Project Manager may need.

Skills on Resume:

• Training Support (Soft Skills)
• File Maintenance (Hard Skills)
• Administrative Duties (Hard Skills)
• Meeting Scheduling (Soft Skills)
• Database Management (Hard Skills)
• Quality Control (Hard Skills)
• Project Support (Soft Skills)
• Mentorship (Soft Skills)

Job Summary:

• May assist in the development, setup, maintenance, and reconciliation of the TMF
• Develop, review, maintain, and track study related items (ie: Regulatory Documents, Site and Team Contact Lists, Frequently Asked Questions Logs)
• Assist in the development of study tools, distribution, and replenishment of study tools through tracking of supply usage. (ie: site binder content, site binders)
• Support internal and external study meetings by creating meeting agenda/minutes, taking of meeting minutes and distribution of meeting minutes
• Maintain actions, decisions, and issues log for the study
• Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools
• May support Biology staff in sample management tracking and shipments
• May assist with site invoice review, patient accruals, and site payments
• Alerts Clinical Supply Team of initial and re-supply drug shipments
• May have direct interaction with study site personnel
• Under close supervision reviews and participates in the QC of data or study related documents

Skills on Resume:

• TMF Management (Hard Skills)
• Document Tracking (Hard Skills)
• Study Tools Management (Hard Skills)
• Meeting Support (Soft Skills)
• Log Maintenance (Hard Skills)
• Data Tracking (Hard Skills)
• Sample Management (Hard Skills)
• Invoice Review (Hard Skills)

Job Summary:

• Provide general administrative support to the Clinical Development team in all aspects of clinical study projects from study planning to close-out and study report
• Participate in establishing, reviewing, and maintaining company standard operating procedures (SOPs), Process Documents related to clinical operations
• Participate in organizing and maintaining Trial Master File
• Participate in the development/review of study plans, documents and study-specific instructions (e.g.: clinical protocol, informed consent, project plan, deviation plan etc.) to ensure that the program meets ICH-GCP and applicable regulations.
• Work together with the Clinical Development team in selection of CROs, vendors
• Take part in the regular sponsor oversight procedures to verify that Clinical Research Organization (CRO) and other vendors fulfill their obligations as agreed.
• Enter safety information to a Safety Database and perform regular reconciliation
• Participate in project meetings, conference, and training calls with Investigators, study sites and write meeting minutes when applicable.
• Assist in site management and oversight for studies were a CRO is not contracted.
• Assist with ordering/dispatch and tracking of trial materials (e.g. study binders. lab supplies, labels etc.)
• Assist in review and reconciliation of clinical data outputs
• Assist with review of Investigator/Site invoices for accuracy (i.e. reconcile against the case report forms (CRFs) and contract)

Skills on Resume:

• Administrative Support (Soft Skills)
• SOP Management (Hard Skills)
• TMF Organization (Hard Skills)
• Document Review (Hard Skills)
• Vendor Selection (Soft Skills)
• Oversight Procedures (Soft Skills)
• Safety Data Entry (Hard Skills)
• Site Management (Soft Skills)

Job Summary:

• Ensure appropriate assessment, selection, and management of vendors for outsourced activities.
• Contribute to contract negotiations with vendors.
• Ensure the clinical elements of vendor SOPs are in place and meet local and global requirements.
• Ensure the external vendor staff are sufficiently trained and experienced to conduct each specific clinical activity.
• Manage and oversee clinical studies (IMP, device, cosmetics) of low to normal complexity/single country.
• Assist in managing and overseeing clinical studies of high complexity/multiple regions.
• Ensure study designs and endpoints for planned clinical studies are in line with the required standards (i.e. ICH-GCP, ISO, any local regulatory standards) and are optimal for meeting the study objectives.
• Manage and adhere to agreed timelines for studies.
• Manage payments to vendors and manage study budgets.
• Assist in providing regular status reports to Senior Management.
• Assist in filing essential study documents and correspondence in the TMF.
• Support the development of slide sets, reports, and publications (abstracts, posters, manuscripts) for internal and external communication of study results

Skills on Resume:

• Vendor Management (Soft Skills)
• Contract Negotiation (Soft Skills)
• SOP Compliance (Hard Skills)
• Staff Training (Soft Skills)
• Study Oversight (Hard Skills)
• Study Design (Hard Skills)
• Budget Management (Hard Skills)
• Status Reporting (Soft Skills)

Job Summary:

• Support the clinical study teams in the execution of clinical studies and clinical projects.
• Assist in the management of study to ensure adherence to timelines and achievements of study goals while ensuring high quality
• Organizes and manages the Trial Master File to maintain up-to-date regulatory documentation for all research sites.
• Provides information for, reconciles and processes investigator payments for subject visits and pass-through expenses according to contractual budges and schedules
• Manage study trackers and provide metrics 
• Partner with Investigators and clinical site staff to ensure optima Sponsor-Site relationships
• Participate in the review and clean-up of study data to support regulatory submission, publication, and presentations
• Liaise with CROs and other clinical vendors to ensure deliverables are met and communication is efficient
• Perform data entry and monitoring as assigned
• Mentor junior Clinical Operations team members

Skills on Resume:

• Study Support (Soft Skills)
• Timeline Management (Hard Skills)
• TMF Organization (Hard Skills)
• Payment Processing (Hard Skills)
• Tracker Management (Hard Skills)
• Site Relationship (Soft Skills)
• Data Review (Hard Skills)
• Vendor Liaison (Soft Skills)

Job Summary:

• Negotiates site requested changes to the Confidential Disclosure Agreement
• Checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations. 
• Prepares Trial Center File and prepare or co-ordinate the development of any other document and review them for completeness and accuracy.
• Assist the LTM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting.
• May be assigned to assist in document review for outsourced trials.
• Support the LTM in drug distribution process.
• Provide administrative and logistical support to the LTM/SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate
• Supports the LTM (e.g., in US) in compiling the List of Investigators for CSR (Appendix 1.4.1) is accurate and complete.
• Maintains and updates CTSRS contact information to ensure appropriate SUA distribution and if applicable disseminates SUA packet.
• Maintains and transmits ERIS Transmittal Summary of 1572 and PI CV to Regulatory Affairs for NDA submission.
• Archives off-site paper Trial Master File.

Skills on Resume:

• Agreement Negotiation (Soft Skills)
• Document Preparation (Hard Skills)
• Meeting Coordination (Soft Skills)
• Document Review (Hard Skills)
• Drug Distribution Support (Hard Skills)
• Administrative Support (Soft Skills)
• Investigator List Management (Hard Skills)
• TMF Archiving (Hard Skills)