Clinical Operations Director
1 month ago
Key Responsibilities
- Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, CSRs, publications
- Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution
- Plan/maintain timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all team members assigned to the study (including vendors)
- Develop and maintain effective relationships with clinical sites and KOLs globally. Lead Site/Investigator meetings and represent study team at industry conferences, as needed.
- Provide guidance on protocol and procedures in the development of eCRF design.
- Liaise with CRAs to identify any trends on data management issues/ICF issues/ quality issues/ investigator site file (ISF) issues/site staff issues to develop solutions.
- Review clinical trial data; monitor data quality and ensure appropriate quality measures are in place to identify any issues with data metrics and data integrity.
- Support and review of study and site budgets, including vendors contracts, POs and invoice approval.
- Study specific vendor oversight, interaction and coordination in conjunction with cross-functional team members, as appropriate.
- Liaise with treatment operations, logistics and manufacturing teams to ensure subject treatment co-ordination
- Ensure cross-functional maintenance of TMF and inspection readiness activities are completed.
- Proactive stakeholder management and communication of progress, risks and issues.
- Line management responsibilities for Associate Director and Manager level Clinical Scientist; may provide mentoring of other members of CDO/company, as applicable.
- Contribute to process improvement initiatives including SOP writing/revision, Guidance Documents, workstreams, etc.
Qualifications & Experience
- Minimum BA/BS in Life Sciences Degree
- Experience leading cross-functional and cross-cultural teams in a matrix environment.
- Extensive industry-sponsored clinical trial management experience required, including experience with biologics or cell and gene therapy in FIH, POC and phase I/II studies.
- Strong knowledge of clinical operations and the regulatory process - experience in independently leading multiple clinical trials including within the oncology therapeutic area.
- EDC experience including trial management, data review, queries, CRF design/review/approval.
- Experience with clinical protocol development and/or regulatory submissions and management.
- Experience writing scientific documents. Experience managing direct reports.
- Experience in taking pre-clinical to Clinical
- Experience in early Development studies
- Experience in Clinical Operations & Clinical Science
Desirable
- Additional post-graduate scientific experience or qualifications, such as an MSc. or PhD
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