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DOCS Senior Site Contracts Manager/ Global Pharma/ Home-based/ Permanent in United Kingdom

Senior Site Contracts Manager/ Global Pharma/ Home-based/ Permanent

Ref #: 30733

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 14-Sep-2021

Description

Responsibilities:

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 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 CROs contracted to negotiate CTAs 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 C&G 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

Experience/Qualifications required:

Bachelors degree in appropriate scientific or business discipline

Strong background experience and/or equivalent competencies in pharmaceutical industry/clinical research

Must have a working knowledge of the clinical development process with 2 years of UK Site 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

Please note you MUST have experience working within clinical research from Pharma or CRO and you MUST have the right to work in UK without the need of sponsorship.

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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