Senior Manager - Clinical Operations
2 days left
- Full Time
The Manager/Senior Manager, Clinical Operations will be responsible for managing the overall operations of an Oncology dedicated clinical research program. This will include project planning, budgeting, resource management, preparing and negotiating Clinical Trial Agreements at each study center as well as participating in the selection and management of CROs and other vendors, initiating and tracking payments made to study sites and vendors, organizing and conducting Investigator Meetings and making clinical presentations. This individual is responsible for and manages study deliverables and is the primary point of contact and interface among the company study team, investigator sites and vendors, proactively managing patient safety and data integrity.
- Supervise CRAs/study center monitoring staff.
- Generate and manage the budget for the applicable clinical program.
- Participate in developing study-related and regulatory documents such as clinical protocols and protocol amendments, informed consent forms, case report forms (CRFs) and CRF completion guidelines, reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts and budgets, advertisement materials, etc.
- Ensure compliance with all applicable regulatory guidelines and GCPs, ensuring overall data quality and integrity, and human subject protection
- Act as cross-functional liaison to ensure study plans remain aligned with current clinical development strategies.
- Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and quality.
- Lead cross functional clinical study team to achieve study milestones.
- Effectively manage multiple studies and/or programs at one time, with good prioritization and time management skills. Employ expertise in study center selection, pre-study qualification, initiation, routine monitoring, and close-out, and ability to complete these responsibilities in compliance with company SOPs.
- Recommend and implement innovative process ideas that impact clinical trials management and cost efficiency.
- Participate in the preparation of Investigator’s Brochures, SOPs, and clinical sections of INDs and IND Annual Reports, DSURs, NDAs, ICF, statistical analysis plan, and clinical study report
- Contribute to the design and maintenance of central clinical files
- BA or BS with bioscience major; RN, PharmD, pharmacy degree, or equivalent.
- Minimum of 5+ years of pharmaceutical industry experience, including clinical operations experience, CRO management and oversight, monitoring clinical studies with appropriate knowledge of GCPs and regulations
- Understanding of cross-function clinical trials processes from study start up through study closure (e.g., data management, safety, biostatistics, medical writing, etc) in order to have a complete understanding of the processes associated with executing a clinical development plan.
- Oncology study management experience required.
- Prefer experience with Phase 1 studies
- Domestic clinical trial experience; international experience is desirable.
Apply for Senior Manager - Clinical Operations
Already uploaded your resume? Sign in to apply instantly