Clinical Trial Manager (f/m/d)

GULP Information Services GmbH

Biberach an der Riß

On-site

EUR 65,000 - 110,000

Full time

14 days+

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Qualifications

Master's degree in natural sciences or related field.
Several years experience in clinical trial supplies or related business.
Experience working in an international environment with team leadership and project management.
Ideally knowledge of regulatory and GMP/GCP requirements for IMPs.
Ability to interpret complex project requirements.
Good software skills (MS Office).
Fluent English and good German skills, both spoken and written.
Strong problem solving capabilities with decision making and results drive.
Excellent communication, negotiation and presentation skills; able to work independently or in a team.

Responsibilities

Responsible for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international Phase I-IV clinical trials.
Act as the leader of the CTSU trial team within the matrix structure, ensuring cross-functional collaboration and interface development for Supply Chain activities.
Provide input to clinical trial protocols and bulk demands, including comparator and non-IMP products, for packaging designs and distribution strategies.
Support investigations as Subject Matter Expert for assigned trials.

Skills

Team leadership

Project management

Regulatory knowledge (GMP/GCP)

English fluent

German language

Problem solving

Communication

Presentation skills

Independent work

Education

Master's degree in natural sciences

Tools

MS Office

Job description

Our mission: We bring people together! We are currently offering an attractive position as CTSU trial manager with one of our customers - a pharmaceutical company in Biberach. A fair compensation and personal support are of course included. Do you have a master's degree in natural science? Then you are a perfect match for us - we look forward to hearing from you! We welcome applications from all suitably qualified persons regardless of any disabilities. Responsible for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international Phase I-IV clinical trials in the Therapeutic Area General Medicine Function as the main point of contact to Clinical Operations and Clinical Development for assigned trials, ensuring the timely and cost efficient provision of clinical supplies Act as the responsible leader of the CTSU trial team within the matrix structure, ensuring cross-functional collaboration and development of interfaces for all Supply Chain activities on the basis of business, regulatory and industry needs Provide input to clinical trial protocols and bulk demands incl. comparator and non-IMP commercial products, to specific packaging designs and efficient distribution strategies Support investigations as Subject Matter Expert for assigned trials

Master's degree in natural sciences or similar disciplines or completed vocational training with experience in clinical trials
Several years experiences in clinical trial supplies or related business
Experience in working in an international environment, as well as team leading and project management experiences
Ideally good knowledge and understanding of the regulatory and GMP/GCP requirements for IMPs
Ability to interpret complex project requirements
Good software skills (MS Office)
Fluent English and good German skills, both spoken and written
Strong problem solving capabilities with the willingness to make decisions and the ability to drive results
Very good communication, negotiation and presentation skillsAbility to work independently as well as in a team