Local Clinical Trial Manager, FSP, client-dedicated, hybrid in Munich

Description

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

Role Purpose

Here at Syneos Health we are currently looking for a Local Clinical Trial Manager opening, to work on a sponsor-dedicated role in a permanent full-time position. The role is 2x per week Munich office based and 3x per week home-based. You will need to visit the office just for printing purposes. 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.

Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure.

Serves as the main point of contact at a country level for internal and external stakeholders

Key Responsibilities And Major Duties

• Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
• Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
• Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
• Assessment and set up the of vendors during study start up period (locally)
• Investigator Meeting participation and preparation
• Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
• Validation of study related materials (i.e. protocol, ICF, patient material)
• Responsible for preparing country specific documents (e.g. global country specific amendment)
• Prepares materials for Site Initiation Visits
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow up. Ensures timelines are met.
• Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities
• Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
• Lead study team meetings locally
• Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
• Management of Site relationships (includes CRO related issues)
• May perform site closure activities, including post-close out
• May act as point of contact for Sites
• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.
  
  

Qualifications

What we are looking for:

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred. Fluent in German and English.
• ≥ 4 or more years’ experience in a CTM position
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
• Demonstrated organizational and planning skills and independent decision-making ability
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Ability of critical thinking and risk analysis
• Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
• Skilled in the use of technology
• Experience with Clinical Trial Management Systems (CTMS), SAP and Contract Management Software (e.g. ARIBA)
  
  

Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.