Offer summary

Qualifications:

Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field., Solid knowledge of GCP compliance and regulatory inspection readiness., Experience with CROs and clinical trial activities, with sponsor experience preferred., Proven problem-solving and collaborative team-building skills..

Key responsibilities:

Provide leadership and guidance to study teams on inspection readiness processes.

Manage inspection readiness planning and develop necessary tools in collaboration with leadership.

Facilitate the development of key inspection deliverables and prepare study teams for audits.

Oversee TMF performance and ensure compliance with inspection readiness standards.

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!

Job Details

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.

Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspections
Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues

Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.

Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
Solid knowledge of drug development and clinical trial processes, including related standards and documents.
Experience in clinical trials systems management and oversight (Veeva preferred)
Proven awareness of sponsor oversight requirements and regulations
Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned