Company: Docs Global (Continental Europe)
Location: Düsseldorf area,Germany
Reference: Ref AS-020272
Closing Date: 23 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Our client is one of the world's leading pharmaceutical companies operating in various therapeutic areas. For our client’s clinical research division, we are currently hiring a Clinical Trial Manager / Local Trial Manager (m/f) office-based near Düsseldorf.
Roles & Responsibilities of the position
Local Trial Manager is a person responsible for local management of a trial in Germany and Switzerland. 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 CTAs, CRAs and Global Trial Managers. 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, 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.
- 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.
- 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
- Good canteen :)
- And much more!
Interested? Please submit your CV to email@example.com. 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, Project Manager, Trial Manager, Study Manager, Oncology, CNS, Cardiology, Immunology, Metabolics, Virology.
2 Globeside, Globeside Business Park
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