Strategy Lead

World Courier Inc.; Pennsylvania; Remote; USD 100,000 - 140,000; Full time

Job summary

Cencora is seeking a Strategy Lead for its Pharmalex team, responsible for providing leadership in clinical research. This remote role involves guiding study teams, managing compliance, and ensuring readiness for inspections. Candidates should have extensive experience in the pharmaceutical industry and strong knowledge of GCP compliance. Join us to make a difference in health and improve lives globally.

Benefits

Health Coverage

Wellness Programs

Training and Mentorship

Qualifications

• At least 6 years of clinical research experience in the pharmaceutical or biotech industry.
• Strong knowledge of GCP compliance and regulatory inspections.
• Experience working with CROs and outsourced clinical trials.

Responsibilities

• Provide guidance on operating model processes and documentation.
• Manage inspection readiness planning and develop inspection deliverables.
• Monitor compliance signals and oversee TMF performance.

Skills

Problem Solving

Negotiation

Team Collaboration

Tools

Veeva

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

We have an exciting opportunity for a Strategy Lead to join our growing Pharmalex team within Cencora!

This role is essential in providing leadership to our evolving team in the US and internationally. This is a remote role based in the United States.

Responsibilities

1. Provide guidance to study teams on operating model processes and documentation, focusing on inspection readiness.
2. Manage inspection readiness planning, developing and maintaining plans and tools in collaboration with cQA and GCP leadership.
3. Develop inspection deliverables such as listings, presentations, storyboards, and audit preparations.
4. Monitor compliance signals and study health metrics to address issues in real-time.
5. Engage Sponsor and CRO SMEs in inspection activities and risk assessments.
6. Oversee TMF performance and processes, ensuring compliance and inspection readiness across study teams and CROs.

Minimum Qualifications

• At least 6 years of clinical research experience in the pharmaceutical or biotech industry.
• Strong knowledge of GCP compliance, regulatory inspections, and study execution.
• Experience working with CROs and outsourced clinical trials; sponsor experience is preferred.
• Understanding of drug development, clinical trial processes, and related standards.
• Experience with clinical trial systems management, preferably Veeva.
• Awareness of sponsor oversight requirements and regulations.
• Skills in problem solving, negotiation, and team collaboration with diverse stakeholders.

What Cencora Offers

We offer competitive compensation, benefits, and resources to foster an inclusive culture that supports your purpose-driven work. Benefits include health coverage, wellness programs, family support, training, mentorship, and more. Visit our website for details.

Equal Employment Opportunity

Cencora is committed to equal opportunity employment, prohibiting discrimination and harassment. We provide reasonable accommodations for individuals with disabilities during the employment process. For accommodation requests, contact us at 888.692.2272 or [e-mail].