Clinical Operations Manager ( Regulatory) - FSP

This role is accountable for performance and compliance for assigned protocols within Poland Country Operations in compliance with ICH/GCP) and country regulations, our company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Under the oversight of the Sr. COM (Senior Clinical Operations Manager) or CRD (Clinical Research Director), the person is responsible for ICF negotiations, IRB Submissions/Approvals and driving Site Ready activities.

Responsibilities include, but are not limited to:

· Executes and oversees clinical trial country submissions and approvals for assigned protocols.

· Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC (Institutional Review Board/Ethics Committee) and the Regulatory Authority for assigned protocols.

· Manages country deliverables, timelines, and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country.

· Contributes to the development of local SOPs (Standard Operating Procedures). Oversees CTCs (Clinical Trial Coordinator) as applicable.

· Coordinates and liaises with CRM (Clinical Research Manager), CTC, CRA (Clinical Research Associate), (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs (Clinical Trial Research Agreement) and local milestones. Collaborates closely with headquarter to align country timelines for assigned protocols.

· Provides support and oversight to local vendors as applicable.

· Enters and updates country information in clinical systems.

· The position has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during study start-up.

· Works in partnership internally with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ (Headquarters) functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions.

Qualifications· Bachelor’s Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.

· Mandatory – at least 1 year experience in Poland EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission.

· Experience of Independently preparing submission (CTC supports with documents collection) to both EC and RA.

· Experience of ICF preparation using templates.

· Skilled knowledge of local regulatory environment and submission and approval processes and understanding of how these impact study start-ups.

· Experience of IMP supplies management at local level (vendors providing background meds, standard of care etc.)

· Experience in validation of translated documents.

About ExecuPharm/Parexel FSP

A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.