Clinical Trial Manager

Company Description

We Value People and we create Value for People by supporting Clinical Research comprehensively, quickly, and efficiently. We offer End-to-end CRO services, Strategic consultation, Custom trial design, Real World Evidence & Data, Fit-for-purpose data, Patient-focused services. Our mission is to Improve People`s Wellness Worldwide by virtue of safer, earlier, more efficient, and accessible diagnoses and treatments. Our vision is to provide modern tools for clinical study research, high-quality real world-data, and evidence with customized and digital solutions.

Role Description

The Clinical Trial Manager (CTM) shall be responsible for the coordination and organization of multiple aspects of clinical projects - from setup through closeout - ensuring high quality delivery and meeting industry standards, and deadlines, all whilst complying with international and national regulations and the requirements of the PVR quality management system.

The CTM shall coordinate site management and monitoring activities leading a dedicated clinical trial team of Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs) and other functions as required by the project.

The CTM is responsible to ensure that all clinical monitoring activities are performed in compliance with ICH GCP, the intermanational and national regulatorions, clinical monitoring plan and other project operational procedures.

Responsibilities

• Management of the clinical trial team (CRA, CTA) and reporting the clinical trial delivery status to the PM from start-up to close-out;
• Ensuring project consistency within and across projects by following PVR and/or sponsor/client SOPs and guidelines;
• Drafting and coordinating review of relevant research-specific documents, including monitoring visit templates, project-specific trainings, project study logs, study operational manuals, clinical monitoring plans, subject recruitment and retention plans, etc.;
• Coordinate the study feasibility process, review the completed feasibility questionnaires and prepare summary;
• Mentoring less experienced project team members on assigned projects to support their professional development;
• Identifying and managing study issues and obstacles, escalating issues whenever required according to the project plan;
• Supporting clinical trial (project) milestone achievement and oversight of the study recruitment process;
• Working with legal and internal and external stakeholders on ensuring site contracts and budget execution;
• Conducting project co-monitoring visits with CRAs as per PVR or sponsor/client standards;
• Taking part in preparation and management of investigator meetings;
• Taking part in audit preparation;
• Managing tasks of CTA and CRA within the project: site assignment, priority and required quality;
• Working closely with study vendors, coordinating their services delivery;
• Participating in Controlled Document development/review, including SQV, SIV, IMV, COV reports and confirmation/follow-up letters.
• Drafting/adapting templates to project needs.
• Reviewing and developing project plans and documents, including Project Management Plan, Project Monitoring Plan.
• Reporting to CPM and/or CEO.
• Assisting CPM in project staff recruitment and selection, conducting qualification interview with CRA and CTA, if required.
• Providing project training to CTA, In-House CRA and CRA.
• Overseeing project and PVR training compliance of the project team in order to guarantee high quality of tasks completion.
• Review of PSSV, SIV, IMV, COV reports and confirmation/follow-up letters;
• Provide project training to CTA and CRA;
• Oversee project and PVR training compliance of the project team in order to guarantee high quality of tasks completion;
• Monitoring activites oversight and ensure compliance with the clinical monitoring plan;
• Perform periodic Trial Manster File (TMF) Quality Control (QC) check;
• Review on the regular basis vendor invoices and ensure that they are in line with vendor work orders and services provided.

Qualifications

• A degree in life or medical science, pharmacy or another health related discipline;
• Knowledge of the legal principles of clinical studies;
• Min 5 year (cumulatively) experience in clinical trials as CTA and/or CRA in start-up, monitoring, and close out of complex clinical trials and CTM. As CTM 2-year experience (min) with tasks on covering start-up and management of trials across several European countries;
• Ability to work in the team to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with sponsor/client to advance work effectively and efficiently;
• Advanced knowledge of current IT applications (including Microsoft Office Word, Excel), CTMS and EDC systems;
• Knowledge of regulations and national / international requirements for clinical studies;
• Knowledge of medical terminology;
• Full professional and conversational English proficiency.

We will be happy to see you in our team