Clinical Outsourcing Manager
2 weeks ago
Position Summary
This individual contributor role has task-level responsibility for in-house and outsourced studies while ensuring adherence to the client's outsourcing strategies within a specific therapeutic area(s) and is accountable to support clinical trial vendor partnerships across select or multiple service categories of clinical trial activities in R&D.
Key Responsibilities
• Drive outsourcing activities by interfacing with operational teams, support groups and service providers for
successful selection, contracting and execution of outsourced studies while ensuring compliance with
regulatory standards, ethical practices, outsourcing and procurement policies and procedures
• Drive the success of projects to meet short-term objectives & adhere to project schedules
• Support Outsourcing team in a variety of tasks across outsourcing, alliance management, FSP operations and
Financial/ Resource accountability
• Communicate with business partners and internal clients regarding contractual issues as needed
• Provide operational expertise and support, guidance and training to teams on all aspects of outsourced work
• Ensure alignment of teams to the related outsourcing strategies
Qualifications & Experience
• Minimum of a BA or BS Degree in Legal, Life science, Business Administration or equivalent. Advanced degree a
plus.
• Clinical development experience of 3 to 5 years of relevant industry experience (pharma, biotech, CRO) required.
• Experience engaging with a wide range of suppliers (e.g., Contract Research Organizations, Cooperative
groups, Clinical laboratories, Core laboratories including ECG and Imaging service providers): initiating,
negotiating and executing legal and/or financial agreements in the clinical trials environment- biotech or
pharmaceutical industry
• Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input
and gathering and incorporating feedback into processes as appropriate
• Effective management of cross-functional, multi-cultural teams and demonstrated ability to work and influence
within a matrix structure
• Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities and
take on new initiatives and improvement efforts
• Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and
balances multiple demands on role in a responsive and professional manner.
• Ability to sustain high levels of performance in a constantly changing environment
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