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Investigator Initiated Research (IIR) Manager II
Ref No.: 18-06649
Location: New York, New York
Job Description: The Clinical and Research Collaboration (CRC) Liaison has primary responsibility for the oversight and management of clinical and research collaborations within assigned Therapeutic Area(s). Clinical and research collaborations are research studies/programs where Pharmaceutical, Inc. partners with an external collaborator(s) to develop, conduct and execute research that would be used to support Pharmaceutical business or regulatory goals. The CRC Liaison will be in support of one or more assets and/or Business/Research Units that engage with external (third party) collaborators that include but are not limited to principal investigators, research organizations, co-op groups, relevant government agencies (e.g., NIH, NCI), other pharmaceutical companies, drug safety monitoring boards, alliance partners, and any vendors that support CRC activities.
The CRC Liaison ensures the timely due diligence review of CRC proposals, contract generation and execution, and forecasts and coordinates drug shipments across the program globally. This due diligence ensures that proper oversight, risk identification and mitigation are addressed before and during these collaborations with third parties. The CRC Liaison also oversees study progress and collaborates with Pharmaceutical colleagues to ultimately ensure compliance with CRC processes, systems and regulations
Internally, the CRC Liaison is the primary Point of Contact for Pharmaceutical colleagues, including TA Medical Teams (within the Business Units and Research Units), Field Medical, PCOs, and Regions, Worldwide Research and Development, Pharmaceutical Sciences, Contracts & Outsourcing, Safety & Risk Management, Outcomes Research, Project Management, Legal, Regulatory, and Finance.
The CRC Liaison also monitors the CRC-related systems and educational needs of internal and external stakeholders to maintain compliance with Pharmaceutical’s CRC policies and guidelines as well as external healthcare law throughout the process. The CRC Liaison will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve CRC functions globally across an asset program.
Position Comments visible to MSP and Supplier: This is a request for a CRC liaison and the candidate will sit in NY and have the ability 2 work remotely up to 2 days a week once fully on boarded. Open to non-local candidates if they can relocate at their own expense. Please ensure 3-5 years of clinical trial experience is demonstrated on the resume as well as Prior Experience in clinical study management or research collaborations and project management.