Clinical Contracts Manager
A global biopharmaceutical corporation located in Northern Central New Jersey is seeking to add a Clinical Contracts Manager to their team for a 12-month contract. The Clinical Contracts Manager will be part of the Outsourcing team to perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol.
The Clinical Contracts Manager will be responsible for: 1) Develop strategy and oversight for all activities for the development and execution of site contracts, for company sponsored study including contribution to site selection process and site prioritization activities. 2) Collaborate with key stakeholders on best practice best practice based on compound alignment and cycle time intelligence. 3) Prepare, distribute, negotiate, and drive to execution site contracts (MCSAs, CSAs, CRADAs, Appendices, etc.) with the appointed CRO or affiliate as appropriate. 4) 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). 5) Ensure an Oversight Plan is in place for each company sponsored protocol, including an escalation plan per study, propose where appropriate, solutions to issues that may arise during a project or contract life cycle.
Location: Summit, New Jersey
Duration: 12-month contract
Compensation: $60-65 per hour
- Must have 2+ years performing clinical contracting and CRO oversight and 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)
- Required to have advanced knowledge of contract terms and conditions (T&C)
- Must have advanced knowledge of financial terms, budgets and financial benchmarking.
- Knowledge of Good Clinical Practice (GCPs) as relates to clinical trial management required.
- Knowledge of contracts workflow systems (e.g. Quickbase) is highly desirable.
- Global trials experience is highly preferred.
Sthree US is acting as an Employment Business in relation to this vacancy.