Reporting to the Chief Medical Officer, the Clinical Operations Lead, manages overall operational implementation and close out of the clinical project to execute on the study and scientific plan and ensures overall quality over the life of a study to meet study endpoints and overall program goals and objectives. Serves as in-house and home-based trial manager for Phase 1, 2 and 3 clinical studies from study start up to clinical study report.
Develops study specific tools and documents, and provides overall direction for the clinical sites and to study team members. Ensures compliance with all global regulations and regulatory guidelines.
Essential Job Responsibilities:
• Conducts and/or oversee all aspects required for selecting, initiating, monitoring and closing research sites according to corporate or CRO SOPs and GCP/ICH requirements, and have the ability to lead a CRO delegated to perform these responsibilities.
• Conducts and oversee all aspects of required for selecting, initiating, monitoring and closing a clinical research site
• Primary contact for internal study team members and external vendors - delegates as appropriate.
• Manages timelines, budget, financial accruals, monitors, home care agency and central laboratory as well as monitor sites when necessary
• Partner with medical writing to manage the process of writing, revising and tracking protocols, amendments, ICFs, CSRs to ensure adherence to regulations, company SOPs and processes, and ensures consistency across clinical trials.
• Manages the development, revision and tracking of all study documents including informed consent and privacy authorization templates, case report forms and completion guidelines, and study specific instructions across clinical trials as well as generating monitoring plans, protocol deviation plans , and reviewing data listings
• Reviews study specific documents in collaboration with the cross-functional project team, and ensures consistency with the protocol and company or CRO designated SOPs and policies.
• Identifies program risks; proactively creates and implements mitigation strategies.
• Participate in evaluating study drug supply requirements and managing logistics.
• Coordination of investigator meetings, advisory boards and development of presentation materials.
• Participates in the evaluation and selection and management of vendors.
• Participates in compilation of data, preparation of clinical study reports and investigator brochures under the direction of the Chief Medical Officer.
• Assists in the preparation of safety, interim and final study reports and resolving data discrepancies with data management.
• Work with legal department to generate, maintain and oversee the contracts with external vendors, provide input into the ongoing budget items and works with vendors to resolve discrepancies.
• Experience, Education and Specialized Knowledge and Skills
• A minimum of BS within a scientific discipline. Master’s degree preferred in a scientific or healthcare discipline
• Minimum of 7 years in clinical and drug development in the pharmaceutical/biotech industry
• Understanding of drug development from pre-IND through NDA
• Extensive experience managing clinical programs, CROs, budgets, and timelines required
• Excellent oral, written, and medical communication skills required
• Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
• Management of CROs, multiple vendors, and complex protocols
• Protocol, ICF, and CSR writing experience required
• A detailed understanding of overall strategic direction, interrelationships and business needs
• Experience is Oncology/Hematology preferred
• Proven experience in the oversight of the operational aspects of all stages of clinical studies
• Ability to organize and manage multiple priorities required
• Knowledge of GCP/FDA/ICH regulations is a must
• Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Proactive and positive management approach
• Maximum flexibility to adapt to changing program needs in real time
• Strong leadership skills
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Engaged, energetic, collaborative and team worker
• Able to perform job duties with minimal guidance
• Focused, detail oriented, sound critical thinker and problem solver.