About Venn Life Sciences: Venn Life Sciences - part of hVIVO plc is an integrated drug development partner offering a unique combination of drug development consultancy, clinical trial design and execution, enabling us to create, plan and execute drug development programs effectively for our customers.

Venn features offices in Breda (the Netherlands) and Paris (France) that offer expertise and capabilities in: chemistry, manufacturing and control (CMC), nonclinical, clinical pharmacology and development, study design and methodology, data management, statistics, and regulatory affairs across a wide variety of therapeutic areas.

We are looking for a Project Manager Biosample Operations to join our team and be a member of our clients’ international study teams.

You will be responsible for the global coordination and logistics of human clinical samples (biosamples) in a fast-paced and complex international setting with internal and external interfaces in compliance with regulatory requirements and Good Clinical Practice (GCP). Your tasks will include designing, planning, executing, coordinating, and monitoring all logistic aspects and activities (collecting and handling samples, shipments, storage, and data reconciliation) regarding all biosamples for various areas (pharmacokinetics, biomarkers and biobanking). This role concerns a responsibility for biosample management activities outsourced to third parties.

If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.

Responsibilities & Accountabilities:

• Plan, organize, and oversee the collection and shipping of biosamples from investigator sites or central labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality;
• Record and compile independently the highly complex analytical and technical biosample and study requirements in plans and checklists based on the clinical trial protocol. Coordinate, harmonize and optimize this information with internal and external interfaces regarding content, scope, time, costs, and regulatory requirements;
• Perform reviews and add required specifications in relevant study-specific documents such as the clinical trial protocol and the electronic case report form and update them regularly;
• Obtain and review independently offers for commissioning a logistics supplier in close cooperation with stake holders (e.g., sourcing manager, project leaders). In particular: Independently specify the work packages to be commissioned, ensuring that the sample logistics aspects are correct and complete and approving the content of the contractual documents;
• Communicate independent, timely and target-oriented with the logistics supplier;
• Coordinate, monitor and steer sample logistics including cost plans and schedules, considering all functions and interfaces involved;
• Specify and perform the data reconciliation independently between the logistics supplier and sponsor, develop solutions in the event of discrepancies, coordinate measures with the relevant interfaces;
• Determine causes, assess effects, initiate measures, document and communicate independently to all relevant functions in the event of deviations;
• Assists in tracking of study costs associated with sample and result management, logistics and shipping as needed 

Qualifications & Experience:

• BSc or higher-level qualification in life sciences or other relevant discipline;
• At least 2 years’ experience in clinical trials;
• At least 1 year project management experience in a project management or combined project management/CRA role;
• Project management experience in logistic arrangements / requirements of human clinical trial samples, e.g., pharmacokinetic samples, biomarkers and biobanking;
• Knowledge and interest in Excel programming and the use of (mathematical) functions is a pre.
• Experience in collaborating with vendors in a global setting;
• Knowledge of GCP and other relevant regulations;
• Understanding of the clinical trial environment including regulatory requirements are of benefit.

 Skills:

• Ability to work independently and as part of a team;
• Excellent attention to detail, planning & organizational skills;
• Ability to find effective solutions or seek internal advice to deal with more complex matters;
• Results and quality-oriented with the ability to multi-task, establish priorities, manage workload, and meet strict deadlines;
• Ability to anticipate potential issues and problems that may arise and proactively identify ways to resolve/mitigate;
• Ability to be flexible and to adapt and work effectively with a variety of situations or individuals;
• Good influencing and collaboration skills, particularly across a multicultural organization;
• Team member with ability to communicate effectively and form positive relationships in and outside the company;
• Demonstrates good judgement and decision-making capability;
• Professional who is experienced and dependable with discretion, enthusiasm, and a positive attitude;
• Hybrid working arrangements possible from the Breda office;
• Flexibility to travel
• Proficiency in PC skills e.g. MS Office;
• Excellent written and verbal communication skills including excellent command of English.

How to apply:

Please forward your CV (in English) by email to careers@vennlife.com