Associate Director, Clinical Operations
New Today
Summary
The Associate Director, Clinical Operations will ensure that study protocols are executed according to the operational plan for assigned studies. Works closely with Clinical Development within the Clinical Operations Program and with all involved functions to ensure high quality deliverables. This role may be responsible for Phase 1 studies, or Phase 2/3 global studies.
Responsibilities
- Supports the clinical trial program lead in the execution of a protocol or program.
- Participates in the review of the protocol, provides an operational feasibility perspective and confirms clarity of procedures.
- Development of or oversight of the development and approval of the informed consent.
- Drives the review and completion of all study-related plans and systems according to timelines and standards.
- Ensures the Clinical Operations Oversight Plan is executed per the plan requirements.
- Oversight of monitoring activities, including review of monitoring reports and co-monitoring as needed.
- Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.
- Oversees study budget, investigator and vendor contracts, budgets, and payments; reviews accruals on a regular basis.
- Proactively identifies risks and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner.
- Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready.
- Develops and drives aggressive recruitment strategies, and ensures CRO is executing the agreed upon strategy.
- Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors.
- May have functional reporting responsibilities or indirect reports (e.g., study team members).
- Supports audit/inspection activities as needed.
- Provides mentorship/guidance to less experienced team members or cross-functional colleagues on study processes/study requirements.
- Remains current on pharmaceutical regulations, guidelines and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
- Maintains knowledge of ICH-GCP, external regulations and procedures.
Experience and Qualifications
- BS/BA degree in a health-related field (e.g., RN) with 8 years or more of clinical trial management experience, including CRO/vendor management (domestic and international and monitoring of budget).
Skills and Abilities
- Collaboration, teamwork, and passion for excellence in clinical operations.
- Ability to be flexible, think "outside the box" and identify new solutions to execution of studies.
- Demonstrated leadership in the management and monitoring of CRO and investigative sites.
- Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management.
- Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations.
- Motivated to work in a fast-paced, high accountability environment.
- Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
- Strong oral and written scientific communications skills.
- Good presentation skills for diverse audiences (investigator meetings, site personnel, and internal project teams).
- Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
- Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
- Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems; ability to work with large databases
- Requires strong understanding of FDA, EU, ICH guidelines
- Ability to travel up to 10%
The expected base pay range for this position is $170,000 - $210,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.
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- Location:
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