Clinical Operations Specialist (contracts & payments focused) – Munich (hybrid) - FSP

Description

Clinical Operations Specialist (contracts & payments focused) – FSP, Munich

Here at Syneos Health we are currently recruiting for a local Clinical Operations Specialist (contracts & budget focused) to be 2x per week office-based in Munich and 3x per week home-based and work on a sponsor-dedicated role for one the world’s leading pharmaceutical companies, with a full-time, permanent contract. The role is part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting. You will be working on an international trials environment, and your responsibility will be local, namely for Germany.

Responsibilities include, but are not limited to:

• Trial and site administration:

o Update clinical trial databases (CTMS) and trackers

• Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents, e.g. eTMF

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

• Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for:

o Develop, control, update and close-out country and site budgets (including Split site budget)

o Develop and maintain contracts (e.g. CTRAs)

o Update and maintain contract templates (in cooperation with Legal Department)

o Calculate and execute payments (to investigators, vendors, grants)

o Ensure adherence to financial and compliance procedures

o Monitor and track adherence and disclosures,

o Maintain tracking tools

• Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)

Qualifications

What we are looking for:

• Min B.A./B.S. (Life Science preferred) or equivalent healthcare experience, but higher degrees are preferred. Native in German and fluent in English

•Experience with payments/budget within clinical environment

• The min would be 1 - 2 years in Clinical Research or relevant healthcare experience, but the more you have, the more qualified you are for this position

• 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 Clin Ops specialists in finance area

• Effective time management, organizational and interpersonal skills, conflict management

• Effective communication with external customers (e.g. sites and investigators)

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks

simultaneously in a changing environment

• Works effectively in a matrix multicultural environment. Ability to establish and maintain

culturally sensitive working relationships.

• Demonstrates commitment to Customer focus, both internally and externally.

• Able to work independently

• Proactive attitude to solving problems / proposing solutions