Clinical Contracts Manager
Newark Metro Area, NJ
- 2+ years performing clinical contracting and CRO oversight;
3+ years in the Pharmaceutical Industry
BA/BS degree or equivalent (Paralegal or Juris Doctorate 2+ years in the Pharmaceutical Industry; 2+ years in performing clinical contracting or equivalent)
1. Negotiation, analytical, meeting management, cross-functional team and leadership skills required
2. Knowledge of Good Clinical Practice (GCPs) as relates to clinical trial management required
3. Knowledge of contracts workflow systems (e.g. Quickbase) is highly desirable
4. Knowledge in developing/maintaining guidelines, training programs, policies and procedures for the functional area
***5. Advanced knowledge of contract terms and conditions (T&C) ***
***6. Advanced knowledge of financial terms, budgets and financial benchmarking ***
7. Advanced problem solving skills in a team environment
8. Demonstrated computer skills (MS Office, MS Project, PowerPoint)
Responsibilities will include, but are not limited to, the following:
Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol.
Deliver clinical site agreements that protect business interests and compliance with regulations and laws concerning the same.
1. Support Global Project Teams during protocol development by:
Develop Strategy and oversight for all activities for the development and execution of site contracts, for Sponsored study including contribution to Site selection process and site prioritization activities.
Collaborate with key stakeholders on best practice best practice based on compound alignment and cycle time intelligence.
2. Take a lead role within the Global Study Teams through:
Prepare, distribute, negotiate, and drive to execution site contracts (MCSAs, CSAs, CRADAs, Appendices, etc.) with the appointed CRO or affiliate as appropriate.
Conduct training and support to appointed CRO and align process and understanding and accountability for deliverables.
Conduct project management for all site contract activities with CRO partners by tracking and measuring project and team timelines and progress through collection of cycle time metrics and other study specific quality; including but not limited to Key Performance Indicators (KPIs).
Working with PRSM outsourcing colleagues on SOW creations for Site contracts.
Communicates metrics, KPIs, and other relevant project information to team and departmental leadership.
Use metrics with CRO s to identify, manage milestones and risks and appropriate escalation.
Oversee an outsourced activity for clinical site contracts:
Ensure an Oversight Plan is in place for each sponsored protocol, including an escalation plan per study, propose where appropriate, solutions to issues that may arise during a project or contract life cycle.
Ensures status reports are provided to appropriate parties on a regular basis. Facilitation of contract workflow and communication by the site contracts group both internally and externally.
Aligned to and aware of strategy for the compound and actively participate in higher level discussions about overall company goals, departmental objectives, and specific project aims.
Escalate issues to senior management in timely fashion.