Job Summary: 

• Determine which key products will be investigated 
• Assess the feasibility, logistics, timeframe, and budget of proposed and confirmed clinical studies 
• Manage the implementation, ongoing evaluation, prioritization, reporting and timely delivery of all operational aspects of allocated projects 
• Coordinate the preparation of documentation for Ethics Committee submissions 
• Ensure programs meet status and compliance as per Company procedures and policies 
• Conduct site qualification, initiation visits, monitoring visits, and study close-out visits
• Maintain effective professional relationships with external customers, investigators, vendors and the internal project team 
• Mentor/coach CRAs including attending site visits
• Participate in User Acceptance testing for all applicable systems being used in a study.
• Collaborate with data management in the review of the edit checks and specifications for the data management plan.

Skills on Resume: 

• Project Management (Hard Skills)
• Clinical Research Oversight (Hard Skills)
• Clinical Trial Operations (Hard Skills)
• Stakeholder Management (Soft Skills)
• Leadership and Coaching (Soft Skills)
• Regulatory Compliance (Hard Skills)
• User Acceptance Testing (Hard Skills)
• Data Management Collaboration (Hard Skills)

Job Summary: 

• Oversee and manage CROs, study contractors and vendors
• Responsible for the collection of study metrics, developing reports, and delivering presentations
• Accountable for applying new processes or business strategies to assigned tasks or activities.
• Contribute to the identification of issues and propose ideas to manage risks to timelines, budget and corporate goals.
• Direct responsibility for delivery of key clinical operation objectives for their study, including clinical trial datasets suitable for analysis and regulatory submission.
• Act as the driver for clinical protocols and amendments and other key study documents, including authoring the Clinical Operations sections
• Serve as the main point of contact for study-level updates.
• Oversee or perform feasibility assessments for new clinical protocols
• Approve clinical study investigators (with team input).
• Communicate with the site regularly, to strengthen relationships and as part of the routine conduct of the study.
• Work with the team to design the format and content of CRFs and patient diaries in conjunction with data management

Skills on Resume: 

• Project Management (Hard Skills)
• Data Management and Reporting (Hard Skills)
• Strategic Thinking (Soft Skills)
• Risk Management (Hard Skills)
• Clinical Operations Leadership (Hard Skills)
• Protocol Development and Compliance (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Feasibility Assessment (Hard Skills)

Job Summary: 

• Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial. 
• Assures currency of required clinical trial documents within Central Files(i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure and normals, etc.) throughout the clinical trial.
• Maintain project-specific regulatory documents inventory systems. 
• Prepares investigator grant payment requests and corresponding cover letters for distribution to the Sponsor´s Finance and Clinical Investigators.
• Maintains clinical grant tracking database for each study, generates periodic reports on the status of grant payments and resolves payment inquiries from investigator sites.
• Assists CPL/CRA in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals.
• Confirms site receipt of shipped IP, alerts responsible CPL whenever IP inventory requires review/re-order and assists with drug reconciliation.
• Assists in securing necessary administrative (non-drug) supplies for clinical trials and processes site requests for shipping supplies
• Maintain clinical trial monitoring/management tracking systems.
• Work with the US Clinical Project Team to ensure the successful completion of a trial in the US.
• Assist with CRA/RCRA
• Set up, populate, and maintain the clinical trial monitoring/management tracking systems

Skills on Resume: 

• Regulatory Compliance (Hard Skills)
• Document Management (Hard Skills)
• Inventory Management (Hard Skills)
• Financial Administration (Hard Skills)
• Logistics Coordination (Hard Skills)
• Supply Chain Management (Hard Skills)
• Data Management (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Represents Medical Affairs in the innovation, technology development, product development, and product lifecycle management teams.
• Develop clinical study synopses, conduct reviews, and address team comments with follow-ups to finalize.
• Ordering and preparation of study supplies.
• Review and verify data entry.
• Review statistics reports and interpret results for clinical performance.
• Support clinical study report development and finalization.
• Provide support for regulatory submissions, such as the development or review of clinical study summaries.
• Prepare presentations and attend key project meetings.
• Prepare technical reports drafts, abstracts, and journal submissions.
• Review/interpretation of medical/scientific literature.
• Monitor trends in laboratory medicine related to capillary blood collection, and communicate findings and interpretations to the MA team.

Skills on Resume: 

• Clinical Study Management (Hard Skills)
• Data Management (Hard Skills)
• Statistical Analysis (Hard Skills)
• Clinical Study Reporting (Hard Skills)
• Regulatory Knowledge (Hard Skills)
• Presentation Skills (Soft Skills)
• Technical Writing (Hard Skills)
• Literature Review (Hard Skills)

Job Summary: 

• Responsible for reviewing clinical study images to ensure compliance with the photographic protocol
• Assist the Clinical Project Manager with all aspects of assigned clinical trial programs
• Identify data issues and follow through with query resolution and troubleshoot photographic/imaging equipment problems
• Provide protocol/imaging equipment training to study personnel via phone, online, and on-site
• Track Vendors and/or internal Study Management Team performance against deliverables, contracts, and timelines
• Assist project teams with trial registration by drafting the Clinical Trial gov and ANZCTR registration submissions
• Appropriately escalates issues on time and ensures resolution
• Support the Director of Clinical Operations or delegate in the development and maintenance of clinical SOPs & trial process
• Build a positive culture within clinical operations and cross-functionally
• Participates in the development, review and implementation of departmental SOPs and processes

Skills on Resume: 

• Clinical Trial Management (Hard Skills)
• Imaging Protocol Compliance (Hard Skills)
• Problem-Solving (Hard Skills)
• Data Management (Hard Skills)
• Training and Education (Hard Skills)
• Vendor Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• SOP Development (Hard Skills)