Clinical Contract Manager

at  IPSEN BIOSCIENCE INC

KNOWLEDGE, ABILITIES & EXPERIENCE

Education / Certifications:

• Master’s degree required in relevant focused area.

Experience:

• 5+ years of post-qualification experience, including relevant international experience in clinical trials contract management.
• Experienced in reviewing standard terms and conditions and legal approved standard clauses within the company’s contract templates and the variations in such clauses as may be needed to address country specific requirements (Global)
• Experienced in negotiating with trial sites’ and service providers’ legal and / or contracting teams across international locations.
• Experience working with R&D teams and cross-functional teams.
• Demonstrated ability to juggle multiple contract / tasks demands at one time whilst remaining responsive to internal clients’ requests.

Languages:

• Fluent in English
• Additional languages a plus

SUMMARY / PURPOSE OF THE POSITION

This is a global R&D level position focusing on supporting the Global Clinical Development Operations (CDO) function as part of the CDO Business Strategy & Operations group, to manage and facilitate the management of clinical trial/clinical project related contracts as per guidance of the legal department and other applicable Company policies and procedures. This includes but is not limited to preparing/reviewing and negotiating standard terms and conditions language and requests for changes to such language by clinical sites in clinical trial agreements and related contracts for all R&D studies worldwide, management of the POA (Power of Attorneys) documents that may be granted to a Service Provider, controlling, and tracking the contract signature process to ensure compliance with the contract approval requirements.
The individual will have a paralegal background and experience with review and feedback on requests for changes to company defined standard T&C sections of master or country specific clinical trial agreements. This person should be comfortable in bridging between clinical operations teams, site contracting teams and legal teams. They must be process oriented, strong on process enhancement and control needs, rigorous and organized. We see the Clinical Contract Manager as a key partner in supporting our clinical trial excellence strategy.

GENERAL RESPONSIBILITIES:

• Keeps up to date on emerging clinical trial related contractual management trends in the pharmaceutical industry including country specific requirements for T&C that differ to the Company standard T&C and how this impacts the CTAs to be executed within that country.
• Develops and implements robust clinical contract management training to R&D personnel as needed, together with associated tools and templates.
• Supports the continuous improvement of standard templates and processes for clinical contracts.
• Ensures smooth collaboration and regular interactions with all the internal stakeholders including Global Ethics and Compliance and Corporate Legal
• Escalates contract related delays / issues to the relevant RDLT member for transparency and issue resolution needs.

EHS RESPONSIBILITIES:

• Complies with applicable EHS regulations and procedures.
• Participates in the site’s EHS performance by reporting risks, malfunctions, or improvements.
• Participates in mandatory EHS training.