clinical data specialist.

Act as a Single Point of Contact (SPOC) for our external contract labs along with External Alliance Manager SPOC.

• Ensure GMP compliance with regulatory requirements.

• Support Analytical Development (AD) departments with their relationship and communication with external laboratories (ECLs) and Contract Development Manufacturing Organizations (CDMOs)

• Support clinical release and stability (CRS) with capacity planning at preferred external contract labs.

• Assist with the initiation of Work Orders (WO’s)/Purchase Orders (PO’s) at external contract labs and CDMOs (through the close collaboration with External Alliance Manager, AD project managers, and Contract Management teams.

• Assist with the scheduling of weekly/monthly analytical meetings with CDMOs and ECLs to support AD project timelines.

• Support the Stability Project Owners, release planners and AD project managers with project timelines and due date tracking of analytical activities at CDMOs and ECLs

• Connection with other ECL SPOC colleague and External Alliance manager to ensure adequate capacity planning at external ECL sites for AD activities.

• Experience with pharmaceutical analytical testing

• Experience in small molecule/synthetic chemistry, analytics, and stability.

• Proven ability to build and maintain customer relationships, shows strong communication skills, internally and externally.

• Ability to foster team productivity and cohesiveness, and to work collaboratively, internally and externally

• Experience with GMP guidelines, policies, pharmaceutical legislation and industry practices concerning analytical development in clinical development

• Knowledge of clinical development processes and phases of development within the pharmaceutical industry.

• Project management and problem solving skills

• Background in pharmaceutical QA processes and procedures (i.e. deviation, CAPA, Change Control, Quality Agreements, audits)

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent.  

• 5 years’ experience in the biopharmaceutical or pharmaceutical industry.

• Fluency in English, Dutch is a plus

In response to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting perks such as:

• Meal vouchers of €7
• Net representation expenses of €80
• Hospitalization insurance
• Car + unlimited fuel card OR kilometer allowance
• 32 vacations
• End of year bonus
• Pension plan
• ECO vouchers
• Training opportunities