Laboratory Study Associate

Role & responsibilities

• Provide support in the set-up of specific meetings with internal as well as external stakeholders (e.g., Operational Excellence Committee (OEC)-meetings with Third Parties, Operational meetings with Third Parties).
• Creation, review, maintenance and tracking of clinical trial documentation related to lab activities.
• Support the collection and storage of study specific documents that are required for the electronic Trial Master File (eTMF).
• Support the creation of Monitors Meetings presentation in collaboration with the LSM.
• Ensure set-up and maintenance of study related databases and tracking tools as required throughout the trial.
• Providing support in the set-up and pro-active follow-up of operational laboratory related activities (e.g. status on lab supplies, sample tracking).
• Ensuring quality check / double-check on specific procedures.
• Provide support to the study budget follow-up (e.g. Introduce shopping cart request, check central laboratory invoices versus study price list and actual service done, ask for credit note, highlight issues related to actual budget versus PO amount to Lab Study Manager).
• Co-ordinate all study archiving activities.
• Assistance in the preparation and support of audits and inspections.
• Act as Quality & EHS coach for team staff, including monitoring of external partners.
• Ensure appropriate documentation and tracking of Quality & EHS related activities.

Preferred candidate profile

Educational Requirements (minimum expected):

• Graduate Degree in life sciences or equivalent experience

Job Related Experience (minimum requirements):

• Knowledge
• Ability to work within teams and networks across functional and geographical boundaries
• Time management skills, ability to set and manage priorities and multiple tasks
• Fluent in speaking and writing in English
• Excellent communication skills
• Eye for details
• Able to evolve and in a changing and challenging environment.
• Stress resistant
• Positive team spirit and interpersonal skills
• Solid expertise in laboratory operations and quality systems
• Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
• Excellent computer skills (Microsoft Office (Excel, Word, PowerPoint), SAP)
• Knowledge of ICH/GCP
• Experience
• More than 3 years expertise in similar or related job

Perks and benefits