Head Of Clinical Operations

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey.

Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation.

Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

Job Description : Head of Clinical Operations Establish Biopharma, Germany :

Position Overview :

The Head of Clinical Operations is responsible for leading the clinical research department, ensuring that all the clients sponsored clinical trials are planned and conducted in alignment with the company's strategic goals.

This role requires direct management of the Clinical Project Management Group, the Head Clinical Project Support, and the Outsourcing Manager.

The position demands strict adherence to governmental regulations, company Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) guidelines.

Key Responsibilities :

Leadership and Management :

• Lead the Clinical Research department, ensuring alignment with the end clients strategic goals.
• Directly manage the Clinical Project Management Group, Head Clinical Project Support, and Outsourcing Manager.
• Ensure clinical trials comply with current governmental regulations, company SOPs, and GCP / ICH guidelines.

Strategic Planning :

• Develop and oversee the outsourcing strategy for the Clinical Research department.
• Supervise budget planning for internal and external costs across the department.

Operational Oversight :

• Assure efficient planning and conduct of clinical trials, maintaining high standards of quality and compliance.
• Serve as the point of contact for pharmaceutical aspects related to Investigational Medicinal Products (IMPs).

Educational Background :

• Relevant scientific degree, with a preference for candidates holding a medical or pharmacy degree.
• Doctorate degree preferred.

Experience :

• Minimum of 3 years of experience in managing direct reports.
• At least 5 years of experience in Clinical Operations, with responsibilities for time and budget management.
• Proven track record in successfully managing clinical trials on both a regional and global scale.

Skills and Competencies :

• Firm knowledge of GCP / ICH guidelines and relevant laws and regulations.
• Demonstrated leadership qualities.
• High communication and cooperation ability.
• Strong ability to work effectively in teams.

Additional Requirements :

• Exceptional problem-solving skills and attention to detail.
• Ability to work under pressure and meet tight deadlines.
• Strong organizational and project management skills.

Application Process :

Interested candidates who meet the above requirements are invited to submit their CV and a cover letter detailing their relevant experience and qualifications.

If you are interested in the above, please apply directly to this advert and we can book in a call to discuss further.