Outsourcing Manager

TechDigital Group; Lawrenceville (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a dynamic individual to manage outsourcing activities for clinical trials. This role involves ensuring compliance with regulatory standards and collaborating with operational teams and service providers. The ideal candidate will possess a strong background in clinical development, with 3-5 years of relevant experience in the pharma or biotech industry. This position offers the opportunity to drive project success while working in a fast-paced, ever-changing environment. If you thrive in a collaborative setting and have a knack for managing multiple priorities, this role could be the perfect fit for you.

Qualifications

• 3-5 years of clinical development experience in pharma, biotech, or CRO.
• Experience in managing cross-functional teams and stakeholder engagement.

Responsibilities

• Drive outsourcing activities and ensure compliance with regulatory standards.
• Support the Outsourcing team in various tasks and provide operational expertise.

Skills

Stakeholder Management

Time Management

Adaptability

Negotiation

Education

BA or BS Degree in Legal, Life Science, Business Administration

Advanced Degree

Job description

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

1. 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.
2. Drive the success of projects to meet short-term objectives & adhere to project schedules.
3. Support Outsourcing team in a variety of tasks across outsourcing, alliance management, FSP operations and Financial/ Resource accountability.
4. Communicate with business partners and internal clients regarding contractual issues as needed.
5. Provide operational expertise and support, guidance and training to teams on all aspects of outsourced work.
6. Ensure alignment of teams to the related Client outsourcing strategies.

Qualifications & Experience

1. Minimum of a BA or BS Degree in Legal, Life science, Business Administration or equivalent. Advanced degree a plus.
2. Clinical development experience of 3 to 5 years of relevant industry experience (pharma, biotech, CRO) required.
3. 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.
4. Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
5. Effective management of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
6. Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities and take on new initiatives and improvement efforts.
7. 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.
8. Ability to sustain high levels of performance in a constantly changing environment.