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Associate Manager, Clinical Site Contracts

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Associate Manager, Clinical Site Contracts
Other Locations:Switzerland- Boudry
DescriptionCelgene 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.(Please note: This is a 24-month "Maximum Duration" contract - with an annual salary, and the benefits of being a permanent employee)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 of any complexity, including contribution to site selection process and site prioritization activities;
Influence and collaborate with key stakeholders on best practice based on compound alignment and cycle time intelligence and engage early on in the feasibility process
Represent PSRM to help educate internal stakeholders regarding site contracts negotiation strategy and timelines to support data driven decision making
Supporting as Global Contract Manager, one point of contact for multiple studies

2. Participate as part of the Global Study Teams through:Partner with MSL's, Clinical and Project Leadership regarding site relationships for key strategic sites
Prepare, distribute, negotiate, and drive to execution site contracts (MCSAs, CSAs, CRADAs, Appendices, etc.) with the appointed CRO or affiliate or directly with the site as appropriate
Conduct training and support to appointed CRO and align process and understanding and accountability for deliverables
Provide feedback to the Business Analytics Lead on the clinical site country budget.
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).
Work with PSRM outsourcing colleagues on SOW creations for Site contracts
Participate to the elaboration and 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.
Identify potential risks and manage issue resolution of moderate to high complexity.

3. Oversee and project manage all outsourced activities for clinical site contracts strategy and execution:Ensure an Oversight Plan is in place for each Celgene sponsored protocol, including an escalation plan per study, propose, solutions to issues that may arise during a project or contract life cycle.
Ensures status reports are provided to appropriate parties both internally and externally on a regular basis.
Awareness of Celgene's strategy for the compound and actively participate in higher level discussions about overall company goals, departmental objectives, and specific project aims.
Manage Escalations as appropriate and highlight to senior management when necessary.

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 proposing alternative solutions or feedback, whenever possible, to facilitate the review.
Participate in the drafting and/or revision of the contracts templates with legal.
In conjunction with Business Analytics, 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.
Actively participate to the maintenance of the Site Contract team knowledge and intelligence globally
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 Business Analytics and Outsourcing compound alignment colleague for strategy on compound lifecycle.
Support line management function by providing feedback on the Site Contracts team goals and processes and acting as Subject Matter Expert.
Lead, Co-lead or actively participate to cross functional regional or global projects.

5. Involved in projects or programs (complex to moderate)Lead moderately complex department specific initiatives and projects
Responsible for making decisions & direction of outcomes
Contribute to strategy and new processes, identify new best practices, and contribute to continuous improvement
Anticipate and prevent problems as well as create backup plans
Requires minimal supervision
Provide direction to teams and provide guidance to lower level staff
Interact with internal and external customers
Capitalize on strengths of relationships/networks to effectively work with cross functional teams and influence these teams as necessary
Update departments with knowledge exchange such as Legal or finance teams and PSRM broader team members.

Skills/Knowledge Required:Advanced knowledge of clinical site contracts negotiations
Advanced knowledge of contract terms and conditions (T&C)
Problem solving skills in a team environment and a commitment to delivering quality in a deadline driven environment
Analytical skills with excellent written, verbal and interpersonal skills
Advanced knowledge of financial terms, budgets and financial benchmarking
Ability to establish and influence team timelines and expectations
Ability to function in a team environment
Proven ability to multi-task
Strong oral, written, and organizational skills
Independent thinking, good judgment and creative problem solving skills
Demonstrated Competencies in:Analytical Thinking
Thoroughness
Detail Orientation
Critical Information Seeking


Ability to address global issues from a program level to study level
Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
Knowledge of Good Clinical Practice (GCPs) as relates to clinical trial management required

Good understanding of Project Management Principles

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