Senior Contract and Grants Analyst

Job ID: 21661
# Positions: 1
Location: US-NJ-Titusville
Experience (Years): ..

Responsibilities:
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. Directs the development of scope of work and analysis of terms and conditions. Provides specialized support to local and global study managers as well as other members of the clinical group in the pricing, planning, execution and control of grants and contracts.
Responsible for analyzing contract requests/needs from operating companies and drafting, negotiating, and finalizing clinical trial agreements and other relevant legal documents as they relate to various clinical projects in the US and/or exUS..

Develop and finalize pertinent master investigator grants globally according to the Client's grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information.
Manage CROs contracted to negotiate CTAs globally. This includes training and supervision.
Lead/conduct contract negotiations on terms and conditions of high-risk and complex agreements and other relevant legal documents as they relate to clinical trials.
Responsible for assessing risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team and legal. Provide advice to stakeholders and others within Client's on contracts and grants.
Establish master agreements or agreement templates with frequently used sites.
Determine potential needs for contract amendments and manage amendment execution.
Assure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
Work with Client's Law Department as necessary to review and analyze contractual terms and conditions in order to reach acceptable language.
Assume responsibility for all aspects of legal document and metrics tracking.
Develop and maintain contract templates in accordance with changes in laws or regulations..
Review, authorize and/or manage payments.
Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs.
Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCO management as well as operating companies, corporate, HCC and QA guidelines.
Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
Collaborate with other members of the Contracts and Grants team and contract consultants to ensure proper dissemination and management of knowledge and to meet team goals and objectives.
Comply with requests from QA and auditors.

Others:
Serve as a subject matter expert for contractual issues for specific geographic areas.
This includes budget, legal terms and legal provisions as well as local practices.
Mentor and train new contract coordinators and analysts.
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

Qualifications:
Bachelor’s degree in appropriate scientific or business disciplines. Masters degree or relevant certification preferred. 5+ years experience and/or equivalent competencies in pharmaceutical industry/clinical research or MBA/Masters degree plus 2 years experience 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 writer), ability to work effectively in cross function teams, strong and proven negotiation and problem resolution skills, a working knowledge of PCs and database management, and business acumen. Must demonstrate innovative spirit, have strong interpersonal and leadership skills, and ability to accomplish substantial tasks with minimal supervision.