Job Title: Manager, Clinical Services
Category: Consulting
Location: TBD, India
Job Type: Full Time
Posted Date: May 21, 2025
Job ID: R259529
About Cencora:
At Cencora, our mission is to create healthier futures by placing our team members at the center of all we do. Every individual here plays an essential role in improving the lives of people and animals around the globe. If you are driven by purpose and innovation, Cencora is the place for you.
Job Description:
This is an individual contributor role within the clinical services team. The selected candidate will be responsible for preparing and reviewing technical and clinical documentation related to In Vitro Diagnostics (IVDs) and medical devices, focusing on compliance with country-specific regulatory requirements for the EU and US markets.
Key Responsibilities:
Draft performance evaluation plans, analytical and clinical performance reports, and scientific validity reports.
Prepare declarations of conformity and summary of safety and performance reports for IVDs.
Develop regulatory checklists and update technical documentation for legacy devices.
Create labelling documents per country-specific standards.
Perform and review systematic literature searches for scientific and medical documentation.
Review technical specifications, product design documentation, and performance evaluation data for IVDs and medical devices.
Experience Requirements:
5–10 years of experience in a relevant domain.
Prior work in clinical affairs, preferably within an IVD company or as a technical documentation (TD) reviewer from a notified body.
Familiarity with European and US regulatory environments.
Required Skills and Expertise:
Strong IVD background
Knowledge of companion diagnostics
Expertise in EQA schemes (External Quality Assessment)
Hands-on experience with immunohistochemistry
Skilled in clinical/medical writing, especially in drafting clinical and performance evaluation reports
Proficient in statistics
In-depth understanding of cancer diagnostics or related therapeutic areas
Experience managing internal or outsourced clinical studies
What Cencora Offers:
Competitive benefits aligned with local market practices (varies by country)
A diverse and inclusive work environment
Equal opportunity employer committed to workplace equity
Reasonable accommodations for individuals with disabilities upon request
Affiliated Company: PharmaLex India Private Limited
📧 For accommodations during the employment process: hrsc@cencora.com
📞 Or call: 888.692.2272
🖥️ Website: www.cencora.com
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