The Clinical Contracts Associate is responsible and accountable for preparation, negotiation and signature of clinical contracts (including budgets) and amendments in the assigned region, adapts templates to geography and country requirements.
Main activities are:
Creates, prepares, reviews and edits contracts, master agreements, work orders, and amendments of a medium complexity level.
Works with Legal and other stakeholders (Compliance, Clinical Quality) on contract language such as indemnification, subject injury language, intellectual property rights, confidentiality, compensation, and other similar matters.
In compliance with Company policies, applicable regulations, Legal Department, negotiates with research sites.
Acts as an interface and point of contact with the site and the project team regarding contractual issues; resolves issues and communicates approach.
Negotiates directly with research sites and ensures that the clinical trial site budgets are in accordance with the clinical protocol requirements and associated company policies.
Seek appropriate approvals from management for budget items in excess of department compliance policy with applicable justification documents
Networks with the Legal Team to assure compliance with laws and company policy.
Advises manager regarding potential issues. Identifies course of action and works in conjunction with management to implement.
Has a firm understanding of the clinical protocols, including study design, procedures to be performed at each visit, duration of trial, etc.
Works in conjunction with manager to ensure contractual requirements and timelines are met; ensures adherence to those timelines; communicates milestones and commitments.
Maintain communication of negotiation status using Company IT systems.
Meet study site activation timelines utilizing effective negotiations skills which results in signed executable agreements.
Participates in site activation calls
As required coordinates and/or supports Clinical HCP Agreements in the assigned region.
Qualifications
Bachelor’s degree or University degree in a relevant field such as Business Administration, Law, Life Sciences or equivalent by experience.
Minimum of 2-3 years of experience in contract management, preferably in a clinical research environment.
Experience in negotiating contracts, preferably within the healthcare or pharmaceutical industry.
Familiarity with clinical trial processes and regulations, including Good Clinical Practice (GCP) guidelines.
Strong attention to detail and accuracy in contract preparation and review.
Proficiency in legal and contractual language.
Proficiency in using company IT systems for communication and negotiation tracking.
Additionally, the ideal candidate should demonstrate a willingness to learn and adapt to changes in regulations or company procedures. They should also be comfortable communicating with stakeholders at various levels of the organization and have a proactive approach to identifying and addressing potential issues.
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.