The Clinical Operations Manager is responsible for managing Clinical Operations vendor selection and contracting activities, managing Clinical Trial Associates, and facilitating the US Clinical Operation department to efficiently manage tasks and share information. The CPM works with Clinical Operation Leaders, Clinical Study Managers, Project Managers and other departments to ensure business objectives are met according to corporate timelines set by the Global Head of Clinical Operations.
•Manage the process to select vendors according to SOPs and Policies including writing the Request for Proposal, consolidating bids, scheduling bid defense meetings.
•Responsible for ensuring the vendor financial requirements are in accordance with the vendor contract and Santen business deliverables.
•Collaborate with Contracts and Procurement department to ensure contracts are executed in a timely manner and according to policy.
•Review invoices for clinical studies and ensure costs are within budget and scope.CPM or PMP certification preferred.
•Thorough knowledge of Trial Master File requirements and direct eTMF experience - Veeva.
•Initiate and manage contract revisions in accordance with changes to the scope of the project.
•Develop and maintain clinical study timelines in conjunction with the Clinical Study Managers and Clinical Operation Leaders
•Recommends improvements to time lines for project completion
•Pro-actively works with members of Clinical Operations to efficiently manage tasks and share information
•Review and approve CRO Project Management Plans, Risk Management Plans, and Communication Plans.
•Facilitate Clinical Operation meetings, as requested, and document action items
•Develop written processes, when necessary, to improve and/or facilitate clinical operations.
•Acts as an advisor to subordinates to meet schedule, resolve technical problems and facilitate proper contract and payment processes in Clinical Operations.
•Assist Clinical Coordination Manager in managing Clinical Trial Associates to provide adequate service to the Global Clinical Operation staff including Human Resource reporting (e.g.MBOs, reviews), ensuring resources are adequately trained, and providing daily direction of tasks.
•Provide guidance on Trial Master File filing and Quality Control requirements, as necessary.
•Minimum 8 - 10 years experience in Project Management or Clinical Operations in the pharmaceutical or biotechnology industry.
•Minimum: Bachelors degree, or equivalent required
•CPM or PMP certification preferred. Thorough knowledge of Trial Master File requirements and direct eTMF experience - Veeva Vault
• Thorough knowledge of GCPs and working knowledge of Food and Drug Administration and other regulatory requirement
•Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment
•Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility
•Attention to detail and quality focused with strong technical and problem solving skills
•Strong communication skills and the ability to operate effectively in an international environment
•Ability to function, communicate, and collaborate cross-functionally and ability to work with culturally diverse global groups
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:
1.Spend considerable time at computer.
2.Stand, kneel and stoop for filing.
3.Use the telephone and speak with external individuals.
4.Travel internationally as needed up to 30% of time. At times may be for extended periods and on short notice