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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.


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 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
Website:  Visit Our Web Site

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