When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Contract Associate is responsible for drafting, negotiating, and finalizing Clinical Site Contracts related to clinical trials throughout the lifecycle of the study, and performs timely and accurate data entry into all Clinical Business Operations operating systems, including but not limited to the company Contract Management System(CMS). The Contract Associate is also responsible for meeting deliverables with high quality and within the project timelines. This role is also referred to as Site Negotiator, Contract Specialist and/or Contract Analyst and may be handled by Study Startup team members in some cases, where expressly delegated to do so. The contracting activity supported by the CBO team is fast-paced, with short deadlines and quick turnaround times therefore Contract Associate must be capable of managing priorities effectively, proactively communicating issues and working in a fast-paced environment.
Essential Functions of the Job: • Draft, review, analyze and negotiate Investigator Site Contracts and budgets, and any other Site related agreements, and escalates to Contract Manager (CM), Clinical Study Manager (CSM) and/or legal as needed; • Complete quality check (QC) of final approved contract and budget documents, and initiates signature process of assigned contracts to the responsible signing parties; • Ensure final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements • Serve as the primary point of contact between CBO and Global Clinical Operations (GCO), Legal, Investigator Sites and external service providers in accordance with the study related activities to meet business needs; • Collect and maintain country and site intelligence information for each country and/or site, and prepares country/site specific contract process flows as needed; • Forecast, set, track and communicate fully executed contract planned dates, and make all efforts to achieve the set planned date, ensuring the CM and study teams are proactively informed of changes and/or risks to the projected dates; • Liaise with CM and BeOne Medicines legal to review and update contract template(s) as needed, including Master Clinical Trial Agreements/Clinical Trial Agreements/Project Agreements or any other Site agreement template(s); • Liaise with CM and BeOne Medicines legal to contribute updates to the BeOne Medicines Legal Playbook guidance document as needed; • Liaise with Investigator Payment Management (IPM) team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeOne Medicines policies; • Ensure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeOne Medicines legal guidelines; • Communicate legal and budgetary issuesBe to internal and external parties per department guidelines, as needed; • Perform legal translation of contract language for Sites, as needed; • Maintain active and regular communication with site personnel and internal BeOne Medicines partners, with regular progress tracking and updates provided throughout the contract lifecycle; • Prepare subsequent contract amendments, note to files and other related contract documents, as needed; • Escalates contracting issues and/or potential delays to internal and external stakeholders, as necessary; • Attend and actively participate in Investigator Site, project-related, CBO, and other meetings, as necessary; • Update and maintain CBO trackers with real-time updates on a regular basis, complete CBO related filing and distribution of contract documents, and maintain Contract Management System (CMS) records, in accordance with CBO and BeOne Medicines policies; • Provides a handoff to the project/payment team upon execution of a site’s final contractual documents • Performs other duties as assigned by management. Supervisory Responsibilities: • none Computer Skills: • Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint etc. • Other Qualifications: • Good knowledge of ICH-GCP, pharmaceutical related regulations and laws; • Good understanding of clinical trial contracting process, and relevant clinical operation
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
