Job Summary:

• Identify training needs, prepare/support the development of training materials to meet those needs, and provide training as required to improve core competency and skill set of the department. 
• Coordinate proactively with CDC Clinical Quality and Training Manager on training supports and plans for CRAs. 
• Plan 1-1 or group trainings as per individual or group needs. 
• Periodic review of ISO train curriculum and completion status. 
• Ensure training files are updated and maintained. 
• Ensure the CRA fully on-boarded (including training of local regulatory requirements) on time as required, in collaboration with CDC CQTM. 
• Be an active mentorship of team members and build talents. 
• Be responsible for ensuring that staff are consistently collaborating and partnering with the CDC PMs / CDC- project teams to ensure transparency and meeting timelines.
• Drive CRA performance, Support CRAs in planning, execution and management of assigned tasks

Skills on Resume:

• Training Needs Analysis (Hard Skills)
• Material Development (Hard Skills)
• Training Coordination (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Documentation Management (Hard Skills)
• Mentorship Development (Soft Skills)
• Team Collaboration (Soft Skills)
• Performance Management (Soft Skills)

Job Summary:

• Drive CRA performance on assigned tasks and responsible for CRA deliverables. 
• Ensure trial conduct, data collection and documentation are conducted by CRAs professionally and to a high standard, in accordance with Novo Nordisk SOPs and local procedures and ICH GCP
• Support/troubleshoot CRAs in planning and execution of various project tasks e.g. site - IRB/IEC submissions, site activation, planning of monitoring visits, managing quality issues at sites, site-specific recruitment and retention issues, site management related issues, etc. 
• Perform periodic performance evaluations as per organization policies and system Collect CRA performance-related feedback from CDC PMs timely and plan feedback sessions with CRAs. 
• Ensure visit reports compliance as per NN SOPs and quality of reports, may need to review reports to check and enhance the quality of reports written Set clear project related goals in coordination with respective CDC PMs and non-project related goals. 
• Perform accompanied visits with CRAs to trial sites focusing on CRA training aspects, CRA performance issues or site performance issues, this includes both skills coaching and personal development. 
• Coordinate with CDC PMs for any project related training /support needed for CRAs. 
• Drive quality mindset among team members and ensure quality in CRA operational tasks, drive risk based monitoring mindset. 
• Support CRAs during Audit/site Inspection readiness activities.

Skills on Resume:

• Performance Management (Hard Skills)
• Trial Supervision (Hard Skills)
• CRA Support (Hard Skills)
• Performance Reviews (Hard Skills)
• Report Quality (Hard Skills)
• Goal Setting (Soft Skills)
• Skills Coaching (Soft Skills)
• Risk Management (Hard Skills)

Job Summary:

• Lead the internal and external study teams in the successful execution of assigned pre and post-market clinical study(ies)
• Meet timelines and deliverables while ensuring compliance with GCP, relevant SOP’s and regulatory requirements
• Develop and execute detailed project plans including site, vendor, and budget management
• Plan and lead investigator and study meetings 
• Author, review, and approve study protocols and supporting documents including site contracts
• Drive study start up, patient recruitment, clinical monitoring, and study closeout
• Plan and coordinate project/protocol specific and therapeutic area training
• Travel to sites and/or vendors to assess project progress and compliance
• Ensure study risks are identified, managed, and mitigation strategies are implemented Clinical Development
• Manage and support continued development of an internal clinical data registry

Skills on Resume:

• Study Leadership (Soft Skills)
• Compliance Management (Hard Skills)
• Project Planning (Hard Skills)
• Meeting Leadership (Soft Skills)
• Protocol Authoring (Hard Skills)
• Recruitment Oversight (Hard Skills)
• Training Coordination (Hard Skills)
• Risk Management (Hard Skills)

Job Summary:

• Conduct clinical data analysis and ongoing data reviews
• Develop protocols in collaboration with internal and external therapeutic experts including clinical and health economics endpoints
• Support and manage Investigator Sponsored Studies
• Participate in collaborative development of study and publication strategy
• Support writing and review of regulatory and publication submissions Other Duties
• Serve as clinical operations resource for cross-functional teams including R&D, marketing and medical education
• Participate in Clinical Operations initiatives, including the development and review of Quality Documents
• Participate in professional organizations and meetings to maintain expertise and support the company mission
• Provide support for Patient Assistance Program

Skills on Resume:

• Data Analysis (Hard Skills)
• Protocol Development (Hard Skills)
• Study Management (Hard Skills)
• Strategy Development (Soft Skills)
• Regulatory Support (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Quality Review (Hard Skills)
• Professional Engagement (Soft Skills)

Job Summary:

• Assess protocol feasibility and advise GUMO Program leadership and PIs, assisting faculty with clinical trial protocol development and selection
• Faculty and industry sponsors will write these protocols, but this position will provide operational insight during protocol development to streamline implementation and reduce risk of protocol deviations
• Assist faculty with management of the portfolio of trials for appropriate balance across disease populations and specific areas of research interest
• Oversee the study start up process, including budget development and negotiations, scientific review committee submission, IRB submission, and other relevant regulatory submissions
• Oversee implementation of research protocols through the entire life cycle of the study, from feasibility assessment through close out, working with process partners to ensure all protocol requirements are met
• Independent management of internal start up procedures in conjunction with IDS Pharmacy, Outpatient clinic, Infusion, Laboratory, Radiology Imaging services, and other UW & SCCA based departments
• Collaborate with various pharmaceutical industry sponsors, contract research organizations, and other third-party vendors and laboratories.
• Ensure quality and integrity of all clinical trials, operating in accordance with all applicable regulatory and compliance guidelines
• Provide oversight for and assist faculty with data analysis
• Develop and maintain close relationships with both internal and external partners

Skills on Resume:

• Protocol Feasibility (Hard Skills)
• Operational Insight (Soft Skills)
• Portfolio Management (Hard Skills)
• Study Start-Up (Hard Skills)
• Research Oversight (Hard Skills)
• Internal Coordination (Hard Skills)
• Collaborative Partnerships (Soft Skills)
• Quality Assurance (Hard Skills)

Job Summary:

• Develop and maintain research procedures for the Program with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines.
• Manage site audits by FDA, study sponsors or internal reviewers as required
• In response to outcomes of these visits, develop process improvements, CAPA reports, and provide retraining to staff members and faculty as applicable.
• Help identify problems with clinical trial start-up and management
• Assist with organized improvement efforts and use problem solving and interpersonal skills to resolve bottlenecks.
• Serve as primary clinical research coordinator 
• Financial & Regulatory Affairs Management
• Understand the total costs and effort associated with clinical research and rapidly develop and defend appropriate budgets to support the research program
• Communicate budget guidelines and restrictions to research staff to ensure overall fiscal compliance.
• Ensure research billing by research staff is in accordance with current Medicare, UW and SCCA budgeting and billing policies and procedures

Skills on Resume:

• Research Standardization (Hard Skills)
• Audit Management (Hard Skills)
• Process Improvement (Hard Skills)
• Trial Management (Hard Skills)
• Problem Resolution (Soft Skills)
• Research Coordination (Hard Skills)
• Budget Development (Hard Skills)
• Fiscal Compliance (Hard Skills)

Job Summary:

• Collaborate with Program Operations Specialist to identify and implement strategies to mitigate areas of financial risk, including proposing and initiating budget changes as needed through the life cycle of the research studies
• Supervise, coordinate and direct the work of 10-14 clinical research staff, and administrative staff 
• Perform all aspects of supervision including hiring, training, and performance evaluation.
• Lead and mentor research staff to support their professional development, provide and facilitate educational opportunities for professional growth.
• Assess staffing needs and schedules, assigning work as needed to support the goals of the research program and the timely completion of deadline driven research activities.
• May perform other duties as deemed qualified
• Manage successful research clinical trials and meet all regulatory and compliance guidelines.
• Collaborate with internal and external partners.
• Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.
• Assist with tracking measurement statistics, and communicate results to Program Leadership.
• Supervision of 10-14 clinical research staff (Sr
• Research Coordinators, Research Coordinators, Research Study Assistants)
• Perform all aspects of supervision including hiring, training, and performance evaluation.

Skills on Resume:

• Financial Risk Mitigation (Hard Skills)
• Staff Supervision (Soft Skills)
• Performance Management (Soft Skills)
• Professional Development (Soft Skills)
• Staffing Coordination (Soft Skills)
• Clinical Trial Management (Hard Skills)
• Partnership Collaboration (Soft Skills)
• Communication and Reporting (Soft Skills)

Job Summary:

• Reporting to the SVP Operation, Quality and Clinical Research the Manager Clinical Affairs will be responsible for assisting in with project management responsibilities for clinical studies. 
• Manage field and clinical site components of clinical studies while acting as the liaison between research centers, Investigators and the Clinical Research function.
• Complete required clinical study documents, and assists with maintaining records necessary for regulatory compliance of GCP.
• Responsible for front end activities related to clinical feasibility including literature reviews.
• Assist with the development of scientific clinical study protocols including the development of case report forms (CRFs).
• Assist with literature reviews and drafts study reports for assigned studies to include any unanticipated adverse event reporting, annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k) and other regulatory submissions with supervision.
• Support the implementation of new clinical systems/processes.
• Ensure site staff including primary investigators and coordinators are appropriately trained and are conducting the study according to the protocol and agreements.
• Manage and monitor the progress of assigned Investigator Initiated Studies including interacting with the primary investigator and site staff, Site Qualification and Initiation

Skills on Resume:

• Clinical Project Management (Hard Skills)
• Site Liaison (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Literature Review (Hard Skills)
• Protocol Development (Hard Skills)
• Report Drafting (Hard Skills)
• System Implementation Support (Hard Skills)
• Study Monitoring (Hard Skills)

Job Summary:

• Develop and maintain successful relationships with key opinion leaders, clinical investigators and researchers at academic and non-academic institutions to achieve mutually agreed upon objectives, including but not limited to investigator-initiated studies, publications, etc.
• Create long-term and short-term planning and supervision of scientific and clinical projects that require interaction with the Executive Team and other associated consultants.
• Provide direction for clinical and non-clinical research engagements.
• Assist in writing and publishing research papers surrounding the techniques and IP developed and used during trials.
• Assist in completing process patent applications surrounding novel techniques developed during experiments.
• Assist in developing the Chemistry and Manufacturing Controls for products and substances to be produced and used in further trials and finished formulations. 
• Coordinate all R&D processes, including regularity and controls for R&D processes.
• Standardize practices and reporting, experimental directive and protocol, operating processes, data collection and organization systems. 
• Assist in developing regulatory assessments and programs/strategies to uncover entry and expansion opportunities in stable markets for goods produced by Olistica.
• Collect and disseminate trial results and information to internal project teams, the CRO, relevant vendors, and associated consultants.
• Coordinate clinical trial correspondence and study and subject newsletters, ensuring that clinical trial documents are prepared and maintained per SOP/GCP requirements.
• Assemble data and complete routine analyses for a variety of reports. 

Skills on Resume:

• Stakeholder Relations (Soft Skills)
• Project Supervision (Soft Skills)
• Research Direction (Soft Skills)
• Scientific Publishing (Hard Skills)
• Patent Assistance (Hard Skills)
• R&D Coordination (Hard Skills)
• Regulatory Strategy (Hard Skills)
• Data Analysis (Hard Skills)

Job Summary:

• Enter data to records or logs, and establish and maintain files.
• Identify opportunities to work with the medical community, discuss research and medical information and facilitate initiation of clinical research studies
• Develop and implement effective educational messaging plans to increase scientific awareness and advocacy of Olistica products among health care providers in the field.
• Find, create, or help develop additional clinical and research opportunities for Olistica to participate in conjunction with other medical professionals, governments, or private parties through grants or other research funds. 
• Assist in the development of a proprietary data solution, utilizing medical staff for guidance and recommendations for buildout.
• Oversee the processes and coordinate the flow of information between the Organization and its various research and development partnerships. 
• Responsible for cultivating and maintaining relationships with academic researchers and leaders and CRO partners.  
• Be expected to attend conferences and seminars to track and monitor market and product trends and regulations. 
• Be expected to compile and analyze data, author white papers, and present findings to scientific and technical experts.  
• Develop and catalog the methodologies and quality controls of the various scientific processes and data collected within the Organization. 
• Responsible for ensuring that the programs run efficiently, and that high-level regulatory, scientific and administrative support is provided in order to maximize the programs’ full potential.

Skills on Resume:

• Data Management (Hard Skills)
• Community Collaboration (Soft Skills)
• Educational Messaging (Hard Skills)
• Opportunity Development (Soft Skills)
• Process Oversight (Hard Skills)
• Relationship Management (Soft Skills)
• Conference Attendance (Soft Skills)
• Regulatory Support (Hard Skills)

Job Summary:

• Lead a team to ensure the health and well-being of study participants enrolled in the clinical research trials. 
• Responsible for the day-to-day management of the Clinical Research Coordinators (CRC), subject visits, clinical trial agreement negotiations, and data collection/entry. 
• Oversight of the resarch unit’s clinical trial agreements and finances
• Clinical procedures including vital signs, electrocardiograms (ECG), phlebotomy, Mixed-Meal Tolerance Testing, and IV placement
• Client engagement and subject/patient recruitment
• CRC hiring, training, and education
• Study Patient/Subject Oversight
• Collecting medical history and monitoring health status 
• Assessing the patient’s study compliance
• Conducting diabetes education and training patients on their diabetes management devices
• Refining procedural checklists for documentation of in-office and phone visits with subjects
• Maintaining the research unit’s Standard Operating Procedures (SOPs)/Institutional Review Board (IRB) documents
• Capturing, reconciling, and interpreting trial-relevant data
• Maintaining internal quality assurance processes
• Representing MDEC in meetings with research sponsoring organizations 

Skills on Resume:

• Team Leadership (Soft Skills)
• Trial Management (Hard Skills)
• Clinical Procedures (Hard Skills)
• Patient Recruitment (Hard Skills)
• Staff Training (Hard Skills)
• Patient Oversight (Soft Skills)
• Data Management (Hard Skills)
• Quality Assurance (Hard Skills)

Job Summary:

• Provides input to the clinical development plan, protocols and operational aspects of clinical trial protocols. 
• Responsible for study start-up and study conduct activities including managing essential documents.
• Contact and resource for clinical trial sites and study coordinators for day-to-day study operations.
• Provides monitoring oversight including authoring of monitoring plan
• Reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.
• Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans
• Ensures the trial master file and essential documents are maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial.
• Managing and communicating the status of study progress and activities.

Skills on Resume:

• Clinical Development Input (Hard Skills)
• Study Start-Up Management (Hard Skills)
• Site Coordination (Soft Skills)
• Monitoring Oversight (Hard Skills)
• Risk Management (Hard Skills)
• Document Maintenance (Hard Skills)
• Inspection Readiness (Hard Skills)
• Study Progress Reporting (Soft Skills)

Job Summary:

• Provide guidance and leadership to representatives of various internal and vendor functions involved in the initiation, conduct/execution and/or finalization of Early Development (ED) and Phase IIa studies. 
• Give study-design related input/feedback, in collaboration with Disease Area Scientist(s) and other internal partners 
• Report trial status, progression and operational issues to the Clinical Team
• Be responsible for the operational implementation of disease-specific and patient segmentation assay systems 
• Serve as the primary point of contact for Service Providers (vendors) 
• Participate in the identification and selection of clinical sites and Service Providers 
• Lead Site feasibility and vendor selection 
• Participate in or leads Clinical Working Group (study team) Meetings including those with the vendors 
• Be in close contact with the Global Clinical Organisation 

Skills on Resume:

• Team Leadership (Soft Skills)
• Design Feedback (Hard Skills)
• Trial Reporting (Hard Skills)
• Operational Implementation (Hard Skills)
• Vendor Coordination (Soft Skills)
• Site Selection (Hard Skills)
• Feasibility Leadership (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary:

• Assure timely submission to Competent Authorities (i.e. HA and EC/IRB), before, during and after the conduct of the study, in collaboration with experts of relevant functional areas 
• Oversee interactions / organize coordination meetings with external vendors involved in the study
• Assure escalation and documentation of issues (site issues, central issues, etc.) 
• Assure study timelines are met, as agreed upon with the CDT 
• Develop, track and keep oversight on study budget and keep study budget within pre-agreed limits 
• Assure overall quality of the study and adherence to study protocol, GCP and applicable SOPs 
• Contribute to generation and review of the protocol synopsis and the full protocol. 
• Contribute to and reviews Clinical Study Report 

Skills on Resume:

• Regulatory Submission (Hard Skills)
• Vendor Coordination (Soft Skills)
• Issue Escalation (Hard Skills)
• Timeline Management (Hard Skills)
• Budget Oversight (Hard Skills)
• Quality Assurance (Hard Skills)
• Protocol Development (Hard Skills)
• Report Review (Hard Skills)

Job Summary:

• Assists as directed with administrative and financial activities associated with the conduct of clinical trials.
• Arrange for study set-up (space, staffing, phones, computers, printers, copiers, binders, storage and other trial-specific equipment).
• Acts as a liaison between site, sponsor and all related agencies.
• Handles all institutional review board documentation and correspondence, including initial submissions, protocol amendments and renewals, informed consent documents and modifications, unanticipated event reporting and serious adverse event reporting.
• Ensures compliance by coordinating all aspects of patient care to research protocols while following GCP guidelines.
• Manages research project databases develops flow sheets and other study-related documents complete source documents and case report forms.
• Reviews as directed confidentiality agreements, sponsor budget templates and clinical trial agreements.
• Prepares regulatory submissions, technical progress reports and sub-contracting reports.
• Assists in completing continuation applications and study extensions.
• Develops recruitment strategies and conducts screenings for study subjects, including interviews and questionnaires.

Skills on Resume:

• Trial Setup Coordination (Hard Skills)
• Site Liaison (Soft Skills)
• IRB Documentation (Hard Skills)
• Compliance Management (Hard Skills)
• Database Management (Hard Skills)
• Contract Review (Hard Skills)
• Regulatory Submissions (Hard Skills)
• Recruitment Strategies (Hard Skills)

Job Summary:

• Reviews as directed protocols to determine financial and resource feasibility.
• Networks with study sponsors for new studies extension.
• Maintain and upkeep all site standard and regulatory operating procedures for research
• Monitors study procedures, scheduling of procedures and charges and coordinate other outside services
• Interfaces with research participants determine eligibility and consent study subjects according to protocol.
• Completes and analyzes ophthalmic-related diagnostic tests and requirements.
• Provide interpretation of diagnostic test results to study participants and related personnel. Keep drug accountability, randomization and subject logs.
• Coordinates with Patient Financial Services to obtain CPT codes and reviews billing for payments.
• Coordinates with Patient Financial Services to ensure purchase orders are processed, deliveries tracked, invoices approved, and transactions tracked within appropriate systems.
• Reviews contracts and indemnification agreements from funding agencies, in coordination with or as directed by Patient Financial Services.

Skills on Resume:

• Financial Feasibility Review (Hard Skills)
• Sponsor Networking (Soft Skills)
• Procedure Monitoring (Hard Skills)
• Participant Interface (Soft Skills)
• Diagnostic Analysis (Hard Skills)
• Billing Coordination (Hard Skills)
• Purchase Order Management (Hard Skills)
• Contract Review (Hard Skills)

Job Summary:

• Coaching, Mentoring and development of CRAs
• Drive CRA performance and support CRAs in planning, execution and management of assigned tasks 
• Other responsibilities and duties which may be required depending on the CDC priorities, in this case the established percentages should be updated
• People Management and Stake Holder Management (Internal and External) 
• Closely work with CDC head on CDC and department related initiatives and meet organizational objectives, e.g. country feasibilities, vendor management, process improvements etc. 
• In coordination with CDC head/CDC-PM, identify trial sites, coordinate site assessments and select appropriate sites to allocate clinical trials. 
• Be responsible for managing CRA workload allocation in line with productivity expectations of CDC, drive teamwork mind-set among the team members. 
• Collaborate with other CRA manager, CDC head, CDC PM and CQTM on functional issues to ensure processes aligned as per CDC strategy and that risks mitigation strategies are identified early and communicated effectively. 
• Collaborate with affiliate Finance, Legal and Compliance for various trial site related tasks, e.g. contract handling, payments, site-resources etc. 
• Promote standardization and consistency between all trials and CRAs in terms of quality, processes, etc. 
• Actively interact with external stakeholders during various meetings (e.g. meeting Investigators during various site visits, local Investigator meetings, local congress, etc.) and manage expectations. 
• Actively participate in management meetings and other local meetings, input to local strategies. 
• Ensure JD is signed off according to local practice including CV and training records are updated periodically
• Approves vacation requests, travel requests, meeting attendance, and expense reports.

Skills on Resume:

• CRA Coaching (Soft Skills)
• Performance Management (Hard Skills)
• Stakeholder Engagement (Soft Skills)
• Site Coordination (Hard Skills)
• Workload Management (Hard Skills)
• Process Standardization (Hard Skills)
• External Collaboration (Soft Skills)
• Documentation Oversight (Hard Skills)