hVIVO - Whitechapel Clinical Biosample Operation Expert in Netherlands
Venn Life Sciences, part of Open Orphan plc, is an integrated drug development partner offering a unique combination of pre-clinical and CMC drug development expertise with clinical trial design and trial management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients.
Our vision is to play a pivotal role in the development of new products enabling disease prevention and treatment. We do this by creating an environment that generates opportunities for employees to stretch their potential and fully exercise their talents thereby consistently providing outstanding services to our clients. We nurture an environment of respect, pro activity, teamwork and above all keep the patient at the heart of what we do.
We are looking for a Clinical Biosample Operation Expert 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) independently. This role concerns a responsibility for biosample management activities outsourced to third parties.
Responsibilities & Accountabilities:
Record and compile the highly complex analytical and technical biosample and study requirements in plans and checklists based on the clinical trial protocol. Coordinate, harmonise and optimise 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 offers for commissioning a logistics supplier in close cooperation with stake holders (e.g., project leaders). In particular: 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
Independent, timely and target-oriented communication 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 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 to all relevant functions in the event of deviations
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
Experience in working 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.
Ability to work independently and as part of a team
Excellent attention to detail, planning & organisational 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
Good influencing and collaboration skills, particularly across a multicultural organisation
Team member with ability to communicate effectively and form positive relationships in and outside the company
Demonstrates good judgement and decision-making capability
Flexibility to travel and work at different locations
Excellent written and verbal communication skills including excellent command of English.
If this seem like you then follow the link to our website and connect to show you interest,
iCIMS ID: 2022-2639
Address Line 1: Lage Mosten 29