The Role:
Reporting to the Clinical Operations Study Oversight Lead, the Sr. Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. You will lead a clinical study with responsibilities including site selection, contract negotiation, budget management, study start-up, conduct and close-out. This role will be responsible for collaborative oversight of a cross-functional study team as well as excellent management of and partnership with CROs and vendors. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharmaceutical company and delivering high quality clinical trial results.
Responsibilities:
- Lead and manage one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management. Lead cross-functional clinical study team to support clinical study delivery.
- Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors.
- Ensures clinical trials are executed according to scope of work, budget, timelines, KPIs, and goal
- Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals.
- Identify risks and propose solutions to facilitate clinical studies.
- Develop and manages the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; manages budget forecasting and accruals in collaboration with finance.
- Oversee and manage the creation, maintenance, QC and close out of TMF activities.
- Ensure appropriate oversight of enrollment, site activation and data collection milestones.
- Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
- Collaborate with the Clinical Data Manager to ensure timely and efficient database lock Participate in data review and reconciliation efforts.
- Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans.
- Lead or co-lead department initiatives to support an expanding organization.
- Travel may be required (10% – 15%).
Competencies Include:
- Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning.
- Excellent problem solving, communication and organization skills.
- Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
- Ability to work in a collaborative environment and build effective working relationships across the organization.
- Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously.
Qualifications:
- At least 5 - 7 years of Clinical Operations experience
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 7+ years relevant experience within the biotech, pharmaceutical, or CRO industry
- Extensive knowledge of ICH-GCP guidelines
- Relevant experience managing early through late Phase clinical trials
- Experience in managing oncology global Phase 3 clinical trials.
- Demonstrated cross-functional leadership fostering team spirit and team motivation
- Capability to challenge status-quo using risk management approach
- Able to thrive in a remote/virtual environment.
