CONTRACTS MANAGER FOR CLINICAL TRIAL AGREEMENTS
The role of the Contracts Manager is to create, negotiate and execute all study contracts, contract amendments, and budgets required for Client's Clinical Trials (Phases I-IV; this role has a Phase I concentration), Investigator Initiated Trials (IIT), and Pharmacology studies.
- Clinical Trial Agreement (CTA) Management.
- Develop CTA per patient budgets using Grant Manager.
- Draft study specific CTA templates.
- Finalize CTA templates and per patient budgets with study teams.
- Negotiate and establish pre-approval and approval workflows; review roles, task timelines and responsibilities; and negotiation parameters with study teams.
- Draft, negotiate, and execute site specific CTAs within established study timelines and study budgets.
- Develop, draft, and negotiate CTA amendments within established study budgets.
- Assist with managing the Data Driven Payment process for assigned studies.
- Lead and coordinate CTA management for large studies.
- Lead and coordinate CTA management for all studies within a project.
- Draft, negotiate, and execute contracts and contract amendments for Client and Pharmacology studies.
- Ensure contracts are executed within fair market standards as appropriate.
- Answer questions and resolve problems concerning all assigned studies and individual contracts.
- Track workflow and contract cost for all assigned studies and individual contracts.
- Engage in process improvement initiatives both inside and outside the Contracts Management Group (CMG).
- Provide some mentoring to junior associates within the CMG.
- Assist with developing and maintaining CMG procedures for contract management as needed.
- Support developing processes, standard templates, and quality definitions and metrics as appropriate.
- BA/BS Degree.
- 3-5 years of experience creating, negotiating and executing contracts in a pharmaceutical or biotech company or Contract Research Organization (CRO).
- Knowledge of the pre-clinical, clinical, and periapproval drug development process required.
- Advanced skills in Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft Access.
- Experience using Adobe Acrobat Professional and Microsoft Office SharePoint.
- Proficiency with specialized industry databases such as Grant Plan/Grants Manager a plus.
- Must possess excellent skill/ability in the following:
- Project Management
- Time Management
- Conflict Resolution
- Dealing with Difficult People
- Written Communication
- Decision Making
- Problem Solving
- Oral Communication
- Team Building
- Influencing Others
- People Relationships
This 9+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: URL blocked - click to apply
ALPHA'S REQUIREMENT #19-01369
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Complex Problem Solving
Coaching And Mentoring