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Contract Clinical Trial Analyst
Há 1 mês
Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
We are searching for the best talent for **Contract Clinical Trial Analyst **to be in **São Paulo **(remote work).
**Purpose**: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.
**You will be responsible for**:
- 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**:
- 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.
DECISION-MAKING AND PROBLEM-SOLVING:
- 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.
- Comply with requests from QA and auditors.
- Able to work independently as well as in a collaborative team environment.
Other:
- English language is required.
- Travel Percentage: 10%
