DOCS Senior Contracts & Grants Analyst in Des Moines, Iowa
Senior Contracts & Grants Analyst
Ref #: 21892
Employment type: Permanent - Full-Time
Location: United States
Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grants and contracts
- Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects.
* Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required
* Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
* Provide guidance to CRO's contracted to negotiate Clinical Trial Agreements globally, inclusive of training and supervision.
* Determine potential needs for contract amendments and manage amendment life cycle.
* Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
* Work with the global contracts team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language.
- Assess risks 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.
* Assume responsibility for all aspects of legal document and metrics tracking.
* Review, authorize and/or manage payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
*Mentor and train new contract coordinators and analysts
* Bachelors degree in appropriate scientific or business discipline
* 3- 5 years experience and/or equivalent competencies in pharmaceutical industry/clinical research
* Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
* Excellent communication skills (both oral and written)
* Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
* Working knowledge of PCs (MS Office suite at a minimum) and database management
* Fluency in English is required
* Previous experience working in virtual teams preferred
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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