Associate Director, Regional Clinical Operations (RECO) - Central US REMOTE

Company: Advanced Clinical
Location: Wilmington
Posted on: November 8, 2024

Job Description:

We are currently searching for a skilled professional to join a well-known client's team as a remote Associate Director, Regional Clinical Operations to support the central US. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.The Associate Director, Regional Clinical Operations (RECO) (United States) responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support Client's pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, Client SOPs, local operating guidelines and local requirements, as applicable. The RECO works locally toward Global Operational goals for recruitment and completion of R&D sponsor trials within timelines and budget. In addition, the position may require management of local CRAs and local oversight of vendors.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 help 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 provides 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.EXPERIENCE5-7 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.EDUCATIONMinimum of Bachelor's Degree in science or a related discipline requiredREQUIREMENTS
• Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and/or IAI.
• 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%.To be a best-fit your strengths must include:
• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
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Keywords: Advanced Clinical, Wheaton-Glenmont , Associate Director, Regional Clinical Operations (RECO) - Central US REMOTE, Executive , Wilmington, Maryland