Senior Site Contract Manager

il y a 3 semaines

Beerse, Belgique Johnson & Johnson Temps plein

**Working with Johnson & Johnson can change everything. Including YOU.**

We are recruiting a **Senior Site Contract Manager **within our Global Clinical Operations (GCO) at Johnson & Johnson.

In this role you will be responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. You will provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

**Your key 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.
- Responsible for delivery on established targets/measurements. 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. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
- 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.
- Work with the global CCS 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 CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
- Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts.
- Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle.
- Exemplary customer focus with vision to drive solutions

**Qualifications**:
**We would love to hear from YOU, if you have**:
**Must haves**: to be considered for this role, please ensure the minimum requirements are evident on your resume
- Bachelor’s degree in appropriate scientific or business disciplines
- 3 to 5 years-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.
- Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GD and operating companies. Comply with requests from QA and auditors.
- Able to work independently as well as in a collaborative team environment.
- Fluency in English required.

**About Janssen, the Pharmaceutical Companies of Johnson & Johnson**:
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national or

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