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Job Details

Clinical Study Manager (m/w)

Company: Docs Global (Continental Europe)
Location: Germany
Reference: Ref AS-026231
Closing Date: 21 Aug 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS has partnered with a highly prestigious organization with one of the most robust pipelines within the industry. This is a great chance for candidates with two or more years of trial management experience to become part of this company and participate in its ongoing successes in the future. Our client offers an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to...

Requirements:

Roles & Responsibilities of the position

The Clinical Study 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.
• Minimum of 2 years of solid clinical project management experience.
• 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.

Remuneration & other details

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• Location: Office based, Düsseldorf area.
• Long term employment intention. 18 months contract via DOCS with a chance to be hired by the sponsor directly afterwards
• Friendly work atmosphere
• Compensatory time-off
• Contribution to pension scheme

To apply:
Interested? Please submit your CV to timo.kindermann@docsglobal.com or call +49 (0)89 666 105 162. We are looking forward to getting to know you.

About DOCS:
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become Trusted Partner. Our five core values are: Our people, Excellence, Accountability, Integrity and Openness.

Apply for this job: Clinical Study Manager (m/w)

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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