Job Ref: 214942110

Date: 2021-10-19 09:48:13

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The Senior Director of Clinical Operations has the responsibility of the oversight, planning, initiation and execution of Clinical Operations programs.

Essential Functions Include:

* Work with the Business Development Department on identifying new or expanding opportunities.

* Lead Clinical aspects of RFI and RFP preparation.

* Assist in the preparation of internal start up meetings for new projects.

* Coordinate, attend, and lead client visits and teleconferences as indicated.

* Oversee or participate in clinical tasks as needed.

* Manage and allocate internal and external resources across Clinical Operations projects based on experience and training. Recognize potential gaps and proactively plan.

* Supervise overall study management by monitoring deliverables, schedules, timelines and external team resources.

* Strategically identify possible improvements to current processes, determine new processes that are needed and initiate and implement new processes.

* May be used as a clinical resource for a project or to reach a milestone.

* Train, mentor and supervise Clinical Operations personnel.

* In conjunction with the VP, Clinical Operations leads Clinical Operations quality or process initiatives.

* Lead Clinical Operations metrics preparation and correct allocation of staff.

* Lead author training programs for clinical operations personnel on new processes.

* Acts independently, has fully developed communication and vendor management skills and takes initiative and action based upon strategic guidance from VP, Clinical Operations.

* Advises VP Clinical Operations of study specific issues, priorities, and problems.

* Proposes proactive, innovative ideas to help resolve challenges faced by the clinical team and the cross functional development team(s).

* Serves as a primary or secondary study team contact to manage the Clinical Operations of the trials and communicating team objectives to ensure quality and success.

* Leads the development of the investigator budget. Ensures effectiveness of site budget/contract process.

* Directs the development of study related documents such as monitoring guidelines, monitoring plan, source document templates, monitoring visit report templates, site tools and worksheets.

* Oversees and contributes to the design and development of case report forms (CRFs), CRF guidelines/instructions, and Data Management Plan.

* Assures clinical trials are in compliance with good clinical practices (GCPs) and in accordance with the FDA and/or EMEA regulations and ICH guidelines.

* Assumes a leadership role to ensure the Clinical Operation milestones and timelines are achieved.

* Travel may be required

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