Senior Study Start-Up Specialist

• Responsible for start-up activities in Belgium and provides local expertise.

• Identify gaps and areas for improvement and propose CAPA.

• The Start-up specialist is responsible for collaborating closely with the Regional Clinical Operations Manager/Start-up Lead to ensure study timelines are adhered to and required quality standards are maintained.

• CRA experience is considered a plus

SSUS activities

• Provide country-specific study start-up expertise, assist on start-up activities, provide support in budget and contract negotiations

• Retrieves essential documents from study site and performs essential document site file reconciliation. Perform independent quality review of submission packages, submit package to EC (and HA), if required.

• Review and translate drug labels, ICF, site specific recruitment materials and other applicable documents.

• Manages sites and site performance by tracking regulatory submissions and relevant milestones

• Ensure inspection readiness of start-up study and site documentation

• Collaborates with Regional Clinical Operations Manager/ Start-up Lead and clinical study sites to ensure timely delivery of start-up milestones

• Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.

• Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.

Sr. SSUS responsibilities

• Mentor and manage junior SSU staff

• Acts as the escalation point person for SSUS(s) with site related issues and concerns

• May serve as subject matter expert for clinical operations, country regulations and SSU-related activities.

Education Required:

• BS in a relevant scientific discipline and 2-5 years of Start-up experience.

• Experience in oncology global trials preferred

Computer Skills:   Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• 2-5 years of Start-up experience in the pharmaceutical or CRO industry

• Excellent communication and interpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Fluent in English  and Dutch (writing and speaking)

Travel:  up to 15%