12 months ago
We are currently working with a client based in NY who are currently looking to recruit for a new role as an Associate Director in Clinical Operations.
Ideally they are looking for a canddiate who can start as soon as possible however they are willing to wait for the right candidate if this isnt possible.
The candidate is responsible for overseeing all facets of assigned clinical studies including:
- Overall management for the planning, execution and reporting of multiple clinical studies/programs (phase I –III) needed to support Health Authority registrations such as INDs, NDAs, MAAs, etc.
- Interact with other teams to ensure consistent performance and superior quality of work.
- Ability to work with CROs, as required, to appropriately execute clinical study plans.
- Assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets/deliverables.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Accountable for the management of clinical trials
- Lead and collaborate on the implementation of clinical development programs.
- Accountable for the management of global clinical studies to ensure GCP compliance and “best practices”.
- In collaboration with Sr. Management produce trial metrics and manage performance of internal teams and CRO.
- Responsible for the quality of the CRO work product and deliverables. Creates vendor oversight plans and strategic documents to oversee and manage multiple CROs and other vendors.
- Provide liaison interface with other line functions
- Identifies and reports issues and solutions.
- Support the development of protocols and study related documents.
- Support in preparing training materials and presentations related to the planning and conduct of the trial.
- Accountable for accuracy of trial information in all trial databases and tracking systems. Responsible for data management and the delivery of individual trial data within agreed upon time frame and in accordance with acceptable ICH quality standards.
- Develops and manages trial budget and project timelines
- Accountable for the Trial master file for studies assigned
- Responsible to coordinate or lead contract and budget negotiations with clinical sites and vendors.
Responsibilities as a member of the clinical operations management team
- Participate in the development and review of clinical outsourcing strategies.
- Determine external clinical trial costs and resources for assigned projects.
- Contribute to standardization of practices across the clinical operation department and studies.
- Represent the company externally to Investigators.
- Supports in the ongoing reviews of department SOPs to ensure compliance and relevance
If you are interested in this opportunity, please send a copy of your resume to firstname.lastname@example.org