Senior Contract Associate, Clinical Site Contracts

BeiGene

6d•Onsite

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Senior Contract Associate is responsible for drafting, negotiating, and finalizing complex 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. 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.

Requirements

Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, SharePoint etc.
Good knowledge of ICH-GCP, pharmaceutical related regulations and laws.
Good understanding of clinical trial contracting process, and relevant clinical operation practices.
Awareness and understanding of compliance and regulatory matters in clinical research.
Proven negotiation, interpersonal and business skills.
Strong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities.
Sense of urgency and strong goal orientation; track-record of meeting deadlines and goals.
Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving.
Proactive and positive team player. Able to maintain high performance during times of ambiguity and change in the work environment.
Must be willing to work in a fast-paced environment with time-sensitive material.
Demonstrated ability to work effectively at all levels of an organization.
Bachelor's degree with 3 or more years of contract/budget experience (legal or administrative management education background preferred) with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor or Up to four (4) years in clinical operations, preferably within the biotechnology, pharmaceutical, and/or CRO industry.

Nice To Haves

Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable.
Has knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area.

Responsibilities

Prepare, negotiate, and finalize clinical trial agreements, ancillary agreements and amendments of company sponsored studies through direct communication with sites.
Responsible for execution of contracts against planned timelines and targets.
Manage budget grid in the contract. Ensure cost calculations are consistent with protocol and agreed with site.
Demonstrates an understanding of records management requirements for contract documents.
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 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 Clinical Site Budgets and Payment 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 issues 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.