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Site Contract Manager - 2406183593W

Description

Site Contract Manager

Location.: Warsaw, Poland

Full time job

Responsible for preparing, negotiating, and finalizing agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts

Principal Responsibilities:

• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.

• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.

• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.

• Manage the contract amendment lifecycle.

• Assume responsibility for all aspects of legal document and metrics tracking.

• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.

• Comply with requests from QA and auditors.

• Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.

• Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.

• Exemplary customer focus with vision to drive solutions

Qualifications

Education and Experience Requirements:

• Bachelor’s degree in appropriate scientific or business disciplines

• 3 experience and/or equivalent competencies in pharmaceutical industry/clinical research

• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus

• Must have a working knowledge of the clinical development process with two (2) years of

negotiation and contract experience

• Familiarity with clinical research processes

• Ability to work effectively in cross function teams

• Strong and proven negotiation and problem resolution skills

• Working knowledge of PCs (MS Office suite at a minimum) and database management

• Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work

• Previous experience working in virtual teams preferred

• Fluency in English required.

• Travel Percentage: 10%

This is what awaits YOU at J&J:

• An opportunity to be part of a global market leader

• A dynamic and inspiring working environment

• Many opportunities to work on ambitious projects and assignments

• Possibilities for development on personal and professional level

Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, or national origin and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw

Organization Janssen-Cilag Polska Sp. z o.o. (7824)

Job Function Clinical Trial Project Management

Req ID: 2406183593W