Note: The job is a remote job and is open to candidates in USA. Advanced Clinical is focused on providing strategic planning and operational delivery of clinical trials. The Associate Director, Regional Clinical Operations will lead local operations, manage relationships with key institutions, and ensure compliance with quality standards while overseeing clinical studies.
Responsibilities
- Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
- Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
- Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
- Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
- Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies. Drives evidence-based site recommendations and selection
- Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across Client and CROs. Align local and central initiatives and advise and guide on effective community engagement activities
- Conduct co-monitoring and site identification visits, as needed
- Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones
- Communicates regularly on country study (ies) status and escalates unresolved issues appropriately to the Regional Clinical Operations Head, North America, Clinical Operations Asset Lead, Clinical Operations Executive Therapeutic Head, and/or Global Study Team
- Collaborates with the Global Study Team, and when necessary, develops and executes the local implementation of the risk management plans, identifying critical issues for the country and ensuring contingencies are established and captured in the study level risk management plan
- For in-house studies, works with the Study Start-Up Team to ensure timely submission of all regulatory, IRB and administrative submissions and helps ensure their appropriate approval
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and implementation of Corrective Action Plan for assigned studies
- Ensures that clinical data from sites are of quality and delivered in accordance with established data entry and cleaning timelines and deliverables
- Represents country and line reports and provides the Global Study Team with actionable country-specific feedback
- Works closely with counterparts in the Regional Clinical Operations Organization to discuss and share country best practices, and contribute to process and initiatives that improve quality and effectiveness and that provide visibility to the Regional Clinical Operations organization
- Ensures that the Client Clinical Trial Management and various business intelligence and tracking systems are complete and up to date for assigned studies
- Proactively incorporate learning and recommendation from study debriefs, best practices and lessons learned
- Maintains oversight and ensures consistency across studies and alignment across CROs for outsourced studies
- Makes an active contribution to therapeutic area strategy teams (i.e. Global Study Team, Asset Lead Meetings, etc.) ensuring knowledge sharing of regional interest. Serves as an active contributor and rotating member on the Protocol Review Committee (PRC)
- Manages issues related to local invoices and provide oversight of any budget reconciliation, in collaboration with Global Clinical Study Manager and relevant departments
- If appropriate, review CRO monitoring plans, training plans and relevant study plans for studies conducted in the region
Skills
- The position requires a minimum Bachelor's degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
- Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and dermatology
- Direct management experience and supervisory responsibility
- Demonstrated leadership and management skills
- Goal oriented, self-starter with proven ability to work independently
- Good knowledge and experience working with external specialist vendors
- Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
- Able to proactively identify issues and provide potential solutions for resolution
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
- Proficient in Outlook/Word/Excel/PowerPoint
- Must be able to travel (domestic and international) up to 10%
Benefits
- Health coverage
- Life insurance
- Disability insurance
- 401k benefits
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