This job is currently Archived,
Posted on : 10 July 2017
- The Clinical Trial Manager (CTM) will be responsible for the operational and logistic aspects of the assigned clinical trial(s).
- Within this role, the CTM will be responsible for adhering to regular planning of tasks in accordance with clinical program timelines, performing the required activities to keep the assigned clinical trial(s) on budget, on time and with the highest standard of quality.
- In addition, the CTM will have to establish day-to-day interactions with the Contract Research Organizations (CROs) and trial sites to ensure sponsor s oversight responsibilities.
Most important tasks of the job:
- Implement, monitor, supervise and direct the assigned clinical trial(s)
- Ensure all trial deliverables are met in accordance with timelines, budget, operational procedures and quality / GCP standards
- Maintenance of Trial Master File (TMF) in strict compliance with ICH/GCP and internal Standard Operating Procedures (SOPs)
- Provide input on relevant part of the clinical trial essential documents (e.g. protocol, Informed Consent Form, Investigator s Brochure)
- Provide input on relevant section of regulatory meetings (e.g. briefing package)
- Prepare and share information (e.g. PowerPoint slides, Word document, Excel Spreadsheets) about clinical trial updates for internal and external team meetings (e.g. regular updates, CRA training, Investigator s meeting)
- Coordinate both internal and external Clinical Team meetings
- Support Clinical Project Management activities when necessary
- Keep tracking of trial budget, reviewing and approving invoices
- Ensure the trial is conducted in compliance with relevant policies, internal Standard Operating Procedures (SOPs), and Working Instructions (Wis)
- It is expected that Clinical Trial Manager will have to travel internationally, as required by the Clinical Trial activities.
- The Clinical Trial Manager will report to and will be supervised by the Head Clinical Operations, within the Clinical Development Department.
Qualification and Experience:
Education: Master of Sciences
Languages: Fluent in English, both written and verbal. Any additional language is a nice to have .
- Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint.
- Good knowledge of GCP and other relevant ICH/regulatory guidelines.
- 5+ years in relevant functions in the Pharmaceutical Industry, or equivalent.
- Proven ability to interact collaboratively in a cross-functional environment required.
- Subject matter expertise in Clinical Operations and related activities.
- Previous experience conducting clinical trials in Europe/US and some Asia-Pacific regions in an outsourcing model is necessary, along with a working knowledge of the EMEA and FDA clinical/regulatory environment.
- As a team player you manage to build a team spirit.
- You are tolerant and considerate to be an active and open communicator and share knowledge and experience with other team members.
- You have a hands on attitude as well as a result-orientated way of work.
- You coordinate, participate and make positive contribution to team meetings.
To be part of a growing team dedicated to improving access-to-medicine, we offer opportunities to bring forward ideas, lead change and ongoing opportunities for personal development and growth in an international company.
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