(Associate) Site Contract Manager
IQVIA
Date: 3 weeks ago
City: Petaling Jaya
Contract type: Full time
Essential Functions
- Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for sponsor and/or investigator-initiated studies through direct negotiation with clinical trial sites
- Responsible for delivery on established targets/measurements.
- Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution.
- Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the pricing guidelines. Participate in and/or lead approval escalations as appropriate.
- 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.
- Work with the global team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members and support functions.
- 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.
- 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.
- Adhere to SOPs, ethics and departmental compliance
- Ensure familiarity with departmental and corporate processes
- Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations (metrics) and archiving retention requirements.
- Analyse 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 following corporate process, systems, and strategies.
- Bachelor’s degree in appropriate scientific or business disciplines
- 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
- Working knowledge of the clinical development process with two (2) years of negotiation and contract experience.
- Excellent communication skills (both oral and written).
- Familiarity with healthcare compliance and other relevant guidance
- Familiarity with clinical research processes.
- Able to work independently as well as in a collaborative team environment.
- Strong and proven negotiation and problem resolution skills.
- Must demonstrate innovative spirit, have strong interpersonal skills, ability to manage a high volume of work.
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