Company: Docs Global (Continental Europe)
Reference: Ref AS-018655
Closing Date: 17 Jan 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Our client is one of the world's leading pharmaceutical companies operating in various therapeutic areas as well as in the field of medical devices. For our client’s clinical research division, we are currently hiring a Local Trial Manager (m/f) office-based near Düsseldorf.
Roles & Responsibilities of the position
- Is responsible for country do-ability and site feasibility assessment in conjunction with CTA, SM and GTM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report.
- Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
- Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
- Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress.
- Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and may support vendor selection.
- May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- Reviews and approves Monitoring Visit Reports submitted by Site 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 language.
- 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
• Variety of therapeutic areas
• Friendly work atmosphere
• Compensatory time-off
• Contribution to pension scheme
• Attractive salary package
• And much more!
Interested? Please submit your CV to firstname.lastname@example.org or call us on +49 89 24440 7115 for more details. 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 a Trusted Partner. Our five core values are: Our People, Excellence, Accountability, and Integrity.
Pharma, Pharmaceutical, Permanent, Clinical Research, Clinical Trial Manager, Clinical Project Manager, Clinical Study Manager, Oncology, Cardiology, Immunology, Virology, Metabolics, Neurology.
2 Globeside, Globeside Business Park
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