Senior Manager Clinical Operations (m/f/d)

Fresenius; Deutschland; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading life sciences company in Germany is seeking an experienced Clinical Trial Manager. The successful candidate will be responsible for planning and overseeing national and international clinical trials, especially in nutrition studies. Key qualifications include a Master's degree in a related field, a minimum of 5 years of relevant experience, and strong project management skills. This role offers the opportunity to work in a dynamic international team.

Qualifikationen

• At least 5 years of experience as clinical trial manager (preferably at sponsor end) with strong expertise in phase-IV studies.
• Hands on experience with project management tools or certification will be preferred.
• Ability to work effectively in international teams and matrix organization.

Aufgaben

• Planning, organization, execution, oversight and evaluation of national and international clinical trials.
• Management of clinical studies according to target market (EU/US/PhM) requirements.
• Cross functional collaboration with central functions (Regulatory Affairs, Pharmacovigilance, Drug Supply, QA).

Kenntnisse

Project management

GCP knowledge

Communication skills

Regulatory compliance

Analytical skills

Ausbildung

Master's degree in life sciences, pharmacy, or a related field

PhD (preferred)

Tools

Project management tools

Clinical trial management software

Microsoft Office

Jobbeschreibung

Your responsibilities:

• Planning, organization, execution, oversight and evaluation of national and international clinical trials (Phase I-IV, focus on nutrition clinical studies) according to ICH-GCP, other applicable legislations and internal standard operating procedures (SOPs). This includes the following tasks:


• Management of clinical studies according to target market (EU/US/PhM) requirements


• Develop detailed project plans, timelines, and budgets estimates for clinical trials and bioequivalence studies


• Selection, instruction and supervision of Contract Research Organizations (CROs)/study sites and collaboration with external service providers (e.g. consultants, medical experts)


• Cross functional collaboration with central functions (Regulatory Affairs, Pharmacovigilance/Drug Safety, Drug Supply and QA etc.)


• Design, development, review of clinical study protocol, CRF and study report, etc


• Review of analytical method validation and analysis documents


• Support in compilation of regulatory documents, including clinical trial applications (CTAs) and amendments


• Response to queries received from regulatory authorities and ethic committees


• Ensure compliance to applicable regulatory requirements and standards


• Monitoring/co-monitoring and supervision of study sites and ensure data integrity and accuracy


• Set up, review and maintenance of trial master file (e)TMF


• Safeguarding the study documentation


• Generation of monthly status reports according to internal reporting system

Your profile:

• Master\'s degree in life sciences, pharmacy, or a related field. Advanced degree (e.g., PhD) is preferred


• At least 5 years of experience as clinical trial manager (preferably at sponsor end) with strong expertise in phase-IV studies


• Hands on experience with project management tools or certification will be preferred


• Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials and bioequivalence studies


• Proficiency in Microsoft Office tools. Experience in clinical trial management software is plus


• Excellent project management skills, including the ability to manage multiple projects simultaneously


• Ability to work effectively in international teams and matrix organization with multi-disciplinary teams


• Excellent communication skills, spoken and written (English)

Mindesteingruppierung/Minimum Grading:
AT (K)