Associate Director, Clinical Operations
Associate Director, Clinical Operations
The Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical study planning and execution (from start-up, conduct, reporting and close out) including timeline, quality and budget). A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.
The Associate Director will interact with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important.
The role is primarily responsible for Operational Study Strategy and Study Execution and in addition may have the responsibility of managing 3 or more direct reports. Responsible for directing and managing the internal and external resources and CROs working on ongoing and planned studies. Will manage operational activities required to support Vericel Clinical projects.
- Primary accountability for operational study-level timeline, cost, and quality deliverables.
- Lead the development of the clinical study plans including critical path activities and interdependencies for assigned clinical stud(ies).
- Develop infrastructure to support all trials.
- Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.
- Establish study milestones and ensure accurate tracking/reporting of study metrics and timelines
- Provide strategic input and lead investigator recruitment/selection across projects or programs
- Proactively assess potential risks to studies and propose mitigation plans.
- Manage all operational functions contributing to clinical trial execution within and across protocols including project planning, trial budgets, resource management and contract research organization selection and management.
- Verify the Trial Master File (TMF) is set up and maintained appropriately throughout all studies, including periodic reviews
- Monitor study budgets against trial progress and bring deviations to the Clinical Executive Management.
- Review and approve Vendor invoices, including investigator grants and pass through costs, as necessary.
- Develop working relationships with study investigators, Data Safety Monitoring Board members and Steering Committee members, as required.
- Ensure study budgets are reconciled with Finance on an ongoing basis.
- Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Vericel’ s quality measures and adherence to scope of work within timelines and budget at a task level. Specifically, track operational study timelines and monitor operational performance metrics through the life of each study;
- Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan.
- Develop and/or review materials for submission to FDA and other global regulatory agencies, if necessary.
- Ensure compliance with CGP, GMP and regulatory guidelines.
- Review and approve standard operating procedures that impact clinical operations.
- Mentor junior team members, as appropriate
- Accountable for ensuring team member compliance with training requirements in the Learning Management System
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- At least 2 years of experience in clinical operations management (studies and staff) required
- 5-12+ years of pharmaceutical /biotech industry experience in areas of clinical trial design, data management, study management, study monitoring, analysis and reporting required
- Strong interpersonal, management, cross-functional and organizational skills required
- Practical knowledge of FDA regulations on good clinical practices (GCP) required.
- Practical knowledge of International Conference on Harmonisation (ICH)-GCP guidelines for clinical trials required.
- Cell therapy experience desirable.
- Bachelor's degree in life sciences/related field
- Advanced degree in a life science highly desirable
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.