Clinical Contract Associate

Location
Cambridge, Massachusetts
Posted
Oct 19, 2021
Ref
R-09086
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Contract

Title:

Clinical Contract Associate

Company:

Ipsen Bioscience, Inc.

Job Description:

This is a position within the Global Clinical Development Operations (CDO) function supporting the R&D Clinical Trial Excellence (CTE) & Services team to manage and facilitate the management of clinical trial/clinical project related contracts as per guidance of the legal department and other applicable Company policy and procedure.

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. We are looking for an individual based in Cambridge, Massachusetts with a legal/paralegal background and experience with reviews of terms and conditions and standard legal language contained in clinical trial agreements. Someone who is comfortable in bridging between clinical operations teams, site contracting teams and legal teams.

Main Responsibilities

Clinical Contract Management

The Clinical Contract Associate works closely with the Clinical Operations project teams, R&D Service Providers, clinical sites and other R&D functional leaders across Clinical Operations, Procurement, Legal, Finance, Corporate Compliance to ensure appropriate contracts are in place for each of the R&D clinical trials.

Main objectives, under supervision:

  • Draft, evaluate, negotiate, execute & archive Clinical trial/ Clinical project related contracts (MSA and complex contracts will remain under R&D Legal however, this position may provide support to R&D Legal review of MSA if requested)

  • Establish and maintain Service Provider relationships by serving as a single point of contact for contractual matters

  • Provide contract-related issue resolution, both internally and externally

  • Monitor and complete contract close-out, extension or renewal, as appropriate

  • Communicate contract-related information to all stakeholders

  • Work closely with R&D legal in addition to the study team leads within R&D

The Clinical Contract Associate is responsible for the overall coordination and management of the contract flow for the study related contracts in such a manner that it is compliant with legal and compliance guidelines, is delivered in the required quality and within the agreed timelines. The Contract Associate participates in the low risk resolution of contract-related issues as they arise and escalates to R&D legal any potential high-risk dispute.

Operations

  • Must operate under strict compliance with legal guidelines in respect to what changes can be accepted to standard T&C versus what need to be referred to legal department for opinion.

  • Has a proactive and common-sense mindset and helps build, enhance and train the right process controls to ensure compliance within the R&D function in regard to contract management.

  • Specifically: Working closely with project, people, and functional leaders across Clinical Operations R&D, Legal, Finance, and Service Providers to ensure appropriate contracts are in place.

General

  • Supports training efforts related to clinical contracts management

  • 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 R&D leadership for transparency and issue resolution needs

  • Is ready to provide back up / support to the other R&D Clinical Contract Specialist when requested

  • 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

Experience / Qualifications/Competencies

  • Graduate law degree or >3 years relevant experience in clinical trial contract reviews and extensive understanding of the legal aspects/requirements of clinical contract standard clauses:

  • 1-3 years’ work experience reviewing standard terms and conditions/ legal approved standard clauses within contract templates and the variations in such clauses as may be needed to address country specific requirements

  • Experienced in negotiating with trial sites’ and service providers’ legal and / or contracting teams across international locations

  • Languages = Fluent in English. Other languages a distinct advantage but not required

  • Strong attention to detail; Strong organizational skills

  • Self-motivated team-player with excellent interpersonal and communication skills, while able to work independently

  • Excellent written/verbal communication and negotiation skills

  • Strong business acumen, curiosity and willingness to continuously learn and work beyond comfort zone (out of the box thinking without compromising compliance and regulatory requirements)

  • Ability to meet multiple contract / tasks demands at one time whilst remaining responsive to internal clients’ requests

  • Strong work ethic, comfortable working in a fast-paced environment with cross-functional teams

  • Assertive and able to play an active role as a partner to clinical research teams

  • Flexibility to work and communicate with colleagues in different time zones when needed

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.