Freelance Regional Clinical Trial Manager

• Ensure appropriate and individual planning of study start up in order to achieve fast initiation of study sites

• Request assignment of CRO and (together with Purchasing and Vendor Management) support CRO contracting process

• Management of on-site logistics, e.g. IVRS and IWRS (IXRS), Investigational Medicinal Product (IMP) supply together with Clinical Trial Supply Unit (CTSU), equipment, lab in cooperation with the CRO

• Develop study specific Investigator Budget Tool. Support contract management with trial-specific information and monitor progress of contracting

• Plan and communicate study budget, timelines, capacities and obtain management approval as required

• Obtain approval for any legal changes in Informed Consent Form (ICF)

• Ensure preparation of Clinical Trial Master File (CTMF) and a sample Investigator Site File (ISF) in cooperation with interfaces

• Ensure timely initial submission to Ethics Committees (ECs) and Competent Authorities (CAs) in collaboration with vendor Regulatory and Start-up Team, monitor approval progress and maintain data in applicable databases

• Actively participate in Investigator Meetings, if required

• Supervise on site monitoring activities (including but not limited to timely turnover of on-site monitoring reports)

• Monitoring of budget, anticipation of budget implications of changes in the study and communication of budget changes

• Ensure appropriate submission to ECs and CAs of relevant documentation on ongoing basis (e.g. CTP amendments, Investigator’s Brochure updates, etc.)

• Manage local/regional patient recruitment and timelines and take appropriate measures to match OPU/regional recruitment commitments, patient retention and milestones

• Perform Co-Monitoring Visits to confirm data quality; CTP, GCP and SOP compliance and to support patient recruitment and retention
• Ensure availability of trial supply (e.g. IMP together with CTSU, equipment, laboratory material) throughout the trial

• Keep timelines for data clarification and data cleaning for data base lock

• Supervise and manage close out activities (collection of essential documents, IMP and equipment; destruction of IMP; completeness of e-CTMF; archiving of trial documents, etc.)

• Ensure end of trial notification and clinical trial reports are provided within respective timelines

• Manage Clinical Trial Coordinators (CTC), CRAs, and Business Partners allocated to the trial

• Manage regional clinical study progress and report progress as well as trial issues to Therapeutic Area Lead, at Clinical Project Review Meetings and to the CTLs at Country Oversight Meetings

• Provide information for Clinical Trial Management System in a timely manner

• Organize and conduct investigator meetings in the region, if needed

• Prepare for and participate in audits and inspections on request

• Evaluate CRA performance

• Ensure collection of financial disclosure questionnaires according to SOP in needed quality

• Degree in a related field (life sciences, nursing, etc.) with at least 5 years of experience in clinical trial management, preferably in a CRO or pharmaceutical environment.
• Proven experience managing regional or multi-site clinical trials successfully.
• Strong communicator with excellent written and verbal skills in English; knowledge of additional languages is an advantage.
• Detail-oriented with a commitment to quality and ethical conduct in clinical trials.
• High-Character: Collaborate with honesty and integrity; shown ability to build trust and work well within a team environment.
• Effective problem-solving and critical thinking skills, with the ability to adapt quickly to changing environments.
• Willingness to travel and have a valid driver’s license.

• A supportive and inclusive work environment with opportunities for personal and professional growth
• Competitive compensation based on experience
• Flexibility and autonomy in how you manage your work
• Engagement in impactful clinical trials that make a difference

Rho Inc