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Job Details

Trial Manager

Company: Docs Global (Continental Europe)
Location: Neuss,Germany
Reference: Ref AS-027544
Closing Date: 18 Feb 19
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

For our client we are currently hiring a Trial Manager - Investigator Initiated Studies (m/f) (1 year contract), under Global Clinical Development Operations/ Medical Affairs Operations office-based near Düsseldorf.

Requirements:

Roles & Responsibilities of the position

• Accountable for the operational oversight of assigned IISs at an operating company level from start-up (post ReCAP approval) through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
• Acts as the central contact for designated project communications, correspondence and associated documentation for assigned IISs.
• Maintains communication with the Sponsor-Investigator and staff during all phases of the IIS regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents.
• Monitors study progress and initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues to IIS team members in support of Medical Affairs/R&D Study Responsible Physician/Study Responsible Scientist.
• Ensures that contracts, budgets and payment schedules are prepared in accordance with IIS contract requirements and HCC/HCBI considerations. As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared.
• Ensures that required safety information (e.g. SAEs/NSAEs, PQCs) are reported and processed according to all applicable SOPs/WIs.
• Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and the IIS Trial Manager Lead
• For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the IIS Trial Manager Lead and Study Responsible Physician/Study Responsible Scientist

Job Requirements

• 4-year University/Bachelor’s degree or equivalent is required. A degree in health sciences, Nursing or related scientific field is preferred.
• Minimum of 5 years clinical research operations experience in the pharmaceutical industry or CRO; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
• Experience in managing investigator initiated studies and study types (interventional, non-interventional and/or registries) is preferred.
• Specific therapeutic area experience may be required depending on the position. Should have a solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid leadership skills are required. Flexible mindset and ability to work in a fast-pace environment
• Ability to work on multiple IISs in parallel in different therapeutic areas is required.
• Proficient in speaking and writing the country language and English language. Good written and oral skills.
• Requires clinical research operational knowledge, project planning/management and communication skills.
• Ability to actively participate and contribute to the productivity and cohesiveness of the team.

Remuneration & other details

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• Friendly work atmosphere
• Compensatory time-off
• Contribution to pension scheme
• And much more!

Interested? Please submit your CV to ruth.guibourg@docsglobal.com or call us on 089 666 105 160 for more details. We are looking forward to getting to know you.

Apply for this job: Trial Manager

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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