Clinical Data Manager - freelance/ remote (Pharma)

Progressive / SThree Group; München; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company is seeking a Clinical Data Manager specializing in Risk Based Quality Management System (RBQM). This fully remote freelance position involves developing strategies, overseeing data management, and leading initiatives to ensure high-quality deliverables. Ideal candidates will have extensive clinical research knowledge and strong project management skills.

Qualifikationen

• Excellent command of the English language.
• Strong understanding of RBQM concepts and practical experience.
• Good grasp of data integrity principles and GDPR regulations.

Aufgaben

• Develop a strategy for implementing RBQM and optimize related technologies.
• Oversee data management services for assigned studies or projects.
• Lead RBQM initiatives and establish best practices.

Kenntnisse

Project Management

Change Management

Risk Management

Data Integrity

GDPR Compliance

Communication Skills

Ausbildung

Experience in Clinical Research

RBQM Implementation Experience

Jobbeschreibung

Clinical Data Manager - Risk Based Quality Management System (RBQM)

Project Responsibilities:

• Project Goal: Develop a strategy for implementing Risk Based Quality Management System (RBQM) and optimize related technologies, processes, and standards.
• Consultation and Knowledge Transfer: Collaborate with Department Leads to create the RBQM implementation strategy.
• Data Management Delivery: Oversee the entire process of data management services for assigned studies or projects. Provide technical guidance to CROs and other vendors to ensure high-quality deliverables are completed on time and within budget.
• Study Activities: Manage assigned study tasks related to Data Management, including setup, execution, and closure.
• Deliverables: Ensure timely, budget-compliant, and accurate completion of Data Management tasks such as creating Data Management Plans, specifying and building databases, handling interim data cuts, locking databases, and archiving studies.
• Leadership in RBQM: Lead RBQM initiatives by incorporating external industry insights to establish best practices and develop innovative solutions.

Qualifications:

• Language Proficiency: Excellent command of the English language.
• RBQM Knowledge: Strong understanding of RBQM concepts and practical experience in RBQM implementation, ideally as an RBQM lead or in a similar role.
• Data Integrity and GDPR: Good grasp of data integrity principles and GDPR regulations, along with strong technical skills in handling data from CROs and other third-party vendors.
• Project Skills: Proficient in continuous improvement, project management, change management, and risk management.
• Study Expertise: Proven experience in the design, conduct, and execution of studies.
• Clinical Research Knowledge: Extensive understanding of the principles, concepts, methods, and standards in Clinical Research.
• Communication Skills: Excellent oral and written communication skills, capable of simplifying complex concepts for clear understanding.

5 days per week - fully remote - Freelance