Clinical Trial Manager / Phase II & III (m/f)

Employer
Docs Global (Continental Europe)
Location
Office, Germany
Salary
Competitive
Closing date
2 Oct 2020

View more

Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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Summary:

DOCS has partnered with a highly prestigious organization with one of the most robust pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry in Germany. We are looking for interested Clinical Trial Managers in Germany who want to become a part of this family and add to the success story.

Roles & Responsibilities of the position:

The Local Clinical Trial Manager will be responsible for managing local clinical studies including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. This role is the primary point of contact at a country level for assigned studies.

Key Responsibilities:

• Work with regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan.
• Responsibility for site feasibility assessment and implementation of any local criteria for site selection.
• Contribution of input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level.
• Lead of local project planning activities to meet recruitment targets. Including but not limited to development of local trial specific procedures and tools, recruitment planning, contingency and risk management and budget forecasting.
• Monitoring of country progress and initiation of corrective and preventive actions when the trial deviates from plans and communication of study progress and issues to study management teams.
• Review and approval of Monitoring Visit Reports submitted by CRA. Identification of issues and/or trends across a trial project and escalation of deviation issues to the Global Trial Manager as needed.
• Establish and maintain excellent working relationships with external and internal stakeholders.
• Active contribution to process improvement; training and mentoring of Clinical Trial Administrators, CRA's and other Study Managers.

Job Requirements:

• Degree in Life Sciences or similar
• Minimum of 2 years of solid clinical study management experience in Germany in a big CRO or pharmaceutical company
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements
• Solid communication and computer skills
• Proficiency in speaking and writing German and English
• Flexible mindset and ability to work at a fast pace within small exploratory study teams
• Ability to work on multiple trials in parallel in different indications

What is offered:

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical sponsors
• Location: Ideally office based in Düsseldorf area. Home Office can be discussed but willingness to visit the office in NRW at least once a week is expected
• Permanent contract
• Great work atmosphere
• Contribution to pension scheme

To apply:
Interested? Please submit your CV to timo.kindermann@docsglobal.com or via our homepage www.docsglobal.com. We are looking forward to getting to know you.

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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