Clinical Contract Specialist

Title:

Clinical Contract Specialist

Company:

Ipsen Pharma (SAS)

Job Description:

Manage Sites contracts for all Interventional/Non interventional/ Projects conducting by GMA Clinops teams. 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.

Management of the POA (Power of Attorneys) documents that may be granted to a Service Provider.

Ensure consistency between GMA Clinops and R&D CDO contracts process.

Coordinate activities of GMA Clinops Clinical contract Associates.

Main responsibilities / job expectations

Clinical Contract Management :

• Establish and maintain Service Provider relationships by serving as a single point of contact for contractual matters.
• Providing trainings to Service Providers on contract process and negotiations.
• Draft, evaluate, negotiate, Clinical study/ Clinical project related contracts (MSA will remain under Legal department however, this position may provide support to Legal department review of MSA if requested)
• Provide contract-related issue resolution, both internally and externally
• Communicate contract-related information to all stakeholders
• Support the Service provider contacting the Sites directly to negotiate the blocking aspects of the contracts.
• Supporting the continuous improvement of standard templates and processes for clinical contracts

Coordination activities :

• Train new Clinical Contract Associates
• Ensure consistency between GMA and RD teams
• Active participation as GMA representative to Legal governance meetings (Lead by Ipsen Legal)

Knowledge, abilities & experience

• Management of contract Process for HCPs/HCOs/Patients/Patients Organizations
• Significant and relevant experience in Medical Affairs Global environment focus on legal aspects
• Extensive capabilities to develop new contracts templates with new regulations (EU & US)
• Ability to advise regarding data privacy protection
• Good knowledge of Tools: Ariba, OneTrust, CoMando

Key Technical Competencies Required

• Legal study background (master’s degree in law)
• Excellent organizational skills
• Team oriented
• Strong knowledge on data privacy regulation (GDPR)
• Excellent capacity to work in English environment (oral/written)

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.