職位描述
職位描述：
Responsibilities
1. Responsible for customizing the Master Clinical Trial Agreement (mCTA) including site / vendor and study specific information;
2. Responsible for analyzing contract requests/needs and translating into appropriate contracts/budgets for company sponsored clinical trial agreements;
3. Lead negotiation of third party contracts and budgets, ensuring the budget meets HCC/HCBI requirements (including budget verification with fair-market value) and contract contains appropriate wording for the third party
4. Acts as primary local/country contact for clinical trial agreements and site specific (budget) templates with clinical trial sites. In case of legal matters, act as liaison between the local study site , Local Trial Manager and the (local) legal department;
5. Calculate study budget based on results of negotiations with third parties;
6. Keep cross-trial and cross-site oversight to create consistency and ensure accumulated learning and updated records from each negotiation round;
7. Create local budget overviews with LTM support;
8. Evaluate potential needs for contract amendments and manage amendment lifecycle; ensuring that contract amendments are appropriately executed;
9. Work with the global C&G, HCC&P,legal affairs, finance teams and GCO Q&C as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Act as liaison in risks assessment of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
10. Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trials and activation of clinical trial sites.
11. Comply with requests from QA and auditors.
12. Responsible for managing the mCTA data oversight: provide qualitative and quantitative input into any revisions of the mCTA and maintain metrics on %adherence to mCTA standards, time to contract sign off to inform strategic discussions with the Research networks
13. Establish and maintain excellent working relationships and networking with external stakeholders, in particular hospital administration and contracting and internal stakeholders, including but not limited by Legal Affairs, Health Care Compliance and global C&G
14. Actively contributes to budgeting, contracting and payment to third party process improvement;
15. May represent functional area in internal and external contracting initiatives
Requirements
University degree or other relevant tertiary education, with relevant working experience and affinity with the legal domain
Minimum of (2 to 6) years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, Sarbanes-Oxley,etc.)
Ability to work effectively in cross function teams and able to influence individuals at all levels within multiple organisations;
Ability to negotiate over conflicting issues and develop win-win outcomes
Previous experience working in virtual teams preferred
Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
Computer literacy – advanced computer skills and detailed knowledge of a variety of software packages (Microsoft applications like Excel, PowerPoint, and Word …). Able to use a range of computer based systems (e.g. CTMS, internet applications, SharePoint) to track and monitor trial and investigational site-related activities.
Excellent communication, negotiation, networking and interpersonal skills. Proficient in speaking and writing the country language and English. Proven track record in contract negotiation and problem resolution.
