Company: Docs Global (Continental Europe)
Reference: Ref AS-018655
Closing Date: 22 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organization with one of the most robust pipelines within the industry. This is a great chance for experienced candidates 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 researching, developing, manufacturing and...
Roles & Responsibilities of the position
Roles & Responsibilities of the position:
The Clinical Study Manager will be responsible for managing local clinical studies, oversight of activities including identification and resolution of issues and communication of timelines and deliverables.
A successful individual is the primary point of contact for assigned studies, responsible for coordinating the local trial team and process improvement.
• 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.
• Act as primary local/country contact for a trial. 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.
• University degree in Life Sciences, Nursing, or relevant clinical research experience is required. Minimum 2 years of solid clinical project management experience is a must.
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid communication and computer skills required.
• Proficient in speaking and writing German and English.
• Willingness to travel with occasional/regular overnight stay away from home depending on the region.
• 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 disease areas
Remuneration & other details
Base salary based on experience level. Pension. Overtime compensation.
Interested? Please submit your CV to email@example.com or call +49 (0)89 244 407 113. We are looking forward to getting to know you.
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.
CRO, Sponsor, Pharmaceutical, Biotechnology, Biotech, Clinical Research, Permanent, Contract, Monitoring.
2 Globeside, Globeside Business Park
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