Senior Start Up Specialist

Job Overview:

Responsibilities include, but are not limited to: Document management: Prepare documents and correspondence Collate, distribute/ship, and archive clinical documents, e.g. eTMF Assist with eTMF reconciliation Execute eTMF Quality Control Plan Site Start-Up responsibilities: Collaborate with other country roles to: Obtain, track and update study insurance certificates o    In a timely manner, provide to and collect from investigators forms/lists for site start-up and submissions Budgeting, Agreement and Payments: Develop, control, update and close-out country and site budgets (including Split site budget) Develop, negotiate, approve and maintain contracts (e.g. CTRAs) Track and report contract negotiations Update and maintain contract templates (in cooperation with Legal Department) Calculate and execute payments (to investigators, vendors, grants) Ensure adherence to financial and compliance procedures Monitor and track adherence and disclosures Maintain tracking tools Collaborate with finance/budgeting representatives for: S/AE Claim Management: Coordinate meetings Update and maintain tracking tools Develop and maintain settle agreements Coordinate for payments Support Financial Clinical Operation Manager(F-COM) for:

Collate, distribute/ship, and archive relevant documents Education/Qualifications:

Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience. Experience:

CORE Competency Expectations:

•       Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills

•       Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.  

•       Hands on knowledge of Good Documentation Practices    

•       Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.   Strong MS Excel skills required.

•       ICH-GCP Knowledge appropriate to role

•       Excellent negotiation skills for CTCs in finance area