Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
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 Celgene 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 Celgene 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.
3. Oversee an outsourced activity for clinical site contracts :
Ensure an Oversight Plan is in place for each Celgene 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 Celgene’s 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
4. Working with peers and stakeholders:
Evaluate changes requested within contracts, identify business and/or legal risk associated with such changes and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate.
In conjunction with Grant Lead ensures that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs.
Escalate issues when needed and encourage resolution at the lowest appropriate level.
Identify new and best practices for continuous improvement.
Member of cross-functional teams; contribute in meetings as appropriate and influence line function change
Comply with audit requests and support to any inspection actions as requested
Collaborate with Grant Lead and Outsourcing compound alignment colleague
5. Train & coach others
Complete training as necessary for customers and stakeholder sand appointed CROs
Update departments with knowledge exchange such as Legal or finance teams and PRSM broader team members.
• BA / BS or Paralegal with minimum 3 years experience
• Minimum 2 years clinical study experience
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. ARIBA) is highly desirable
4. Knowledge in developing/maintaining guidelines, training programs, policies and procedures for the
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)
9. Excellent written communication & multi-tasking skills
10. Ability to establish and achieve timelines and expectations
11. Good understanding of Project Management Principles