Basic Purpose and Objective: The basic purpose of the Contracts Specialist position is to manage the day-to-day contract process with the objective of productively negotiating, finalizing and delivering clinical trial agreements in an efficient and timely manner
Supervisory Responsibilities: No direct supervisory responsibilities
Duties and Responsibilities (according to relevant guidelines, laws and PPD SOPs, WPDs, policies, practices and procedures)
Drafting, , reviewing, negotiating and finalizing agreements with clinical study sites and principal investigators including confidentiality agreements, budgets and payment schedules (collectively, âœInvestigator Agreementsâ), as well as other related agreements, as directed by the Line Manager
Drafting and review of Investigator Agreements according to Company policy, rules, practices and procedures and implement and manage the process for internal and external approval, execution and filing of agreements
Identifying and assessing legal, financial and operational risks per PPD contract considerations and Client negotiation parameters in contracts and providing recommendations and alternative resolutions to department management
Projecting a favourable image of the contracts group internally within PPD and externally with clients and other third parties
Liaising and establishing effective relationships with clients as directed by the Line Manager and/or internal PPD functional groups, as required
Ensuring correct filing (electronic and hard copy) of templates, draft documents and fully executed documents
Identifying and assisting with the implementation of process improvement opportunities
Accurate and timely completing of applicable contract status tracking reports and hour burn reports to aid company tracking of contract workflow, metrics and revenue for all agreements
Educating PPD functional groups and clients, as directed by the Line Manager, on contracting or budgetary requirements and processes including appropriate contract templates
Identifying and protecting PPD from unnecessary business and legal risks
Ensuring compliance with audit requirements of PPD, recognized external authorities and clients
Conducting follow-up calls, as necessary, with internal and external clients and sites
Assisting with identification and implementation of process improvement opportunities
Working within and completing study contracts within study budget allotment of hours, while minimizing overburn, related to Investigator Agreements
Working with other internal functional departments to facilitate coordination of the different site start-up activities where fully executed contracts trigger other study start-up deliverables within mutually agreed up on timelines
Note that the above list of duties and responsibilities is not intended to be exhaustive, and the job holder may be required to carry out additional or varied tasks, dictated by the specific requirements of the location or project allocation.
Qualifications: Degree or equivalent in a legal, business, financial, or life sciences related subject
Skills and Knowledge:
Detailed understanding of the principles of contract law including a general understanding of the other laws that influence contract language, such as business, intellectual property and local tax and stamp laws
General understanding of business and financial principals that relate to service agreements
General understanding of the pharmaceutical product development process and the involvement of CROs therein
General understanding of the contractual and business issues between pharmaceutical companies and CROs
Effective communication skills (verbal and written) in English
Effective communication skills (verbal and written) in language spoken at your local place of work
Ability to organise competing priorities logically and review outstanding contract risk and issues escalated by team
Numerate with excellent computer skills (particularly MS Excel, Word, PowerPoint and Internet)
Capable, with appropriate oversight, of drafting and negotiating contract provisions and negotiation parameters
Strong attention to detail
Ability to plan and deliver quality end product against constant time pressures
Ability to work in a team or independently
Ability to provide direction to other employees
Excellent analytical and decision based thinking
Responsible for understanding and adhering to PPD and Client SOPs, WPDs and department processes and procedures.
Experience:
Experience in contract drafting and negotiation and budget preparation and negotiation
Experience in drafting and negotiating Investigator Agreements
Experience in negotiating budget and payment schedule terms and conditions in Investigator Agreements
Please send in your applications with detailed salary information to rachel.kee@ppdi.com.
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