Company: Docs Global (Continental Europe)
Reference: Ref AS-019281
Closing Date: 28 Oct 16
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 / Clinical Project Manager (m/f) office-based near Düsseldorf.
Roles & Responsibilities of the position
Local Trial Manager (Clinical Project Manager) is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
• 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 and coordinates local trial team activities in compliance with Standard Operating Procedures (SOP) and applicable regulations. 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).
• 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.
• 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 089 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, Project Manager, Project Management, Trial Manager, Study Manager, Study Leader.
2 Globeside, Globeside Business Park
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.