Clinical Trial Manager - Germany

If you are an experienced Clinical Trial Manager who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Clinical Trial Manager to join our Project Management team. Reporting to the Senior Clinical Trial Manager (SCTM), Global Project Coordinator (GPC) or Clinical Trial Manager (CTM) with a Study Lead role, this position will be remote-based.

Responsibilities:

This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:

• Provides support to the CRAS and the sites by:
  • Reviewing and approving monitoring reports within the agreed timelines
  • Ensuring any detected issue (Protocol Deviation or non-Protocol Deviation) is reported in the Clinical Trial Management System and is adequately followed until closure
  • Preparing / reviewing training materials for the Global CRA calls and performing presentations
  • Participating in the preparation of global communications to the CRAs/Sites
  • Answering any questions the CRAs and sites have during the trial
  • Following on trial activities with CRAs (+/- sites directly if needed),(e.g. samples Management (missing PK samples/tumor and blood samples, open queries, lab kits re-supply to sites), ECG (delivery/return of the ECG machine when provided to sites, missing ECGs, open reconciliation queries)
  • Oversees activities conducted by regional Third Party Organizations (TPOs) including the organization of regular meetings with these TPOs
• Prepares, or oversees, the submission of the documents to the Ethics Committee and Regulatory Authorities (if applicable) (eg. amended protocol/Informed Consent Form or other patients' documents, Investigator Brochure)
• Ensures appropriate TMF maintenance by:
  • Reviewing, approving, and submitting the essential documents at country level for filing in the TMF and identifying missing documents
  • Performing periodic review of the Trial Master File (TMF Quality Controls (QCs) at country/site levels and following up with the support of the CTAs on any detected finding until resolution
  • Overseeing of the periodic review of the TMF performed by the CTAs
• Maintains information up to date in the Clinical Trial Management System (CTMS)
• May provide expertise and functional supervision of the CTA(s) tasks
• Negotiates amendments to financial agreements with investigators/sites as per trial requirements
• Reviews and approves invoices (e.g. sites; TPOs) and supports finance with site/TPO fee reconciliation
• Participates in audits, prepares answers to audit findings at site level and may act as an audit coordinator with other TRIO departments involved in order to consolidate answers to the audit reports
• May participate in the development/review of trial operational documents
• May review and validate data entered in the Electronica Data Capture (if applicable)
• May participate in working groups and in the revision of procedures involving the PM Department
• May participate in the CTM Mentoring program and/or Country Subject Matter Expert (SME)
• Level 2: In addition to the previous tasks and responsibilities, may act as a Lead CTM
  • Participates with the Supervisor in the determination of resource requirements and timelines for trial set-up, maintenance, and closure
  • Is the subject matter expert of procedures for a specific trial. As such, they are responsible for:
  • Developing, reviewing, and approving Trial Specific Written Instructions/ Plans
  • Training and overseeing the activity of the PM team involved in the trial
  • Confirming the PM team involved operates according to the trial instructions/Plan
  • Escalating any issues that could impact the trial timelines

Qualifications:

• Bachelor's degree as a minimum
• Scientific background (Nurse, Scientist, Pharmacist, M.D.)
• Advanced proficiency in MS Office specifically in Word, Excel and PowerPoint
• Level 1: At least, 1 year of experience in monitoring or coordination of clinical trials
• Level 2: At least, 3 years of experience in monitoring or coordination of clinical trials with demonstrated strong proficiency in Level 1 responsibilities
• Excellent English level, both orally and in written
• Good communication skills, both in written and oral
• Excellent organizational skills with a strong attention to detail
• Ability to learn new systems and navigate within those systems
• Ability to work independently and work as a team member
• Excellent knowledge of ICH/GCP

What TRIO Can Offer You:

• Competitive salary
• 30 days paid vacation days
• Flexible working hours
• Work from Home
• Home Office Allowance
• Monthly Internet Allowance

Integrity • Teamwork • Passion

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