Centralized Clinical Team Lead II - Ukraine

Summary of Responsibilities: Management of complex projects under the direction of a Project Manager/Director as assigned. Ensure site monitoring responsibility for clinical studies are conducted according to Fortrea Standard Operating Procedures (SOP), ICH Guidelines and GCP. Work closely with project teams in implementation of best Trip Report review practices and applicable project plans as assigned (implementation of Initiatives either independently or with team). Proactively identified opportunities for process improvements and work collaboratively with project team in case further action required. Complete required training according to required timelines. Follow applicable departmental SOPs and Work Instructions. Proactively identified opportunities for process improvements. Lead the process improvement opportunities and manage the implementation of associated revised processes and procedures. Follow project issue escalation process and Fortrea Corrective action issue resolution process or clinical operations issues. Ensure follow-up on issues and risks and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues. Proactively identify risks and report them to the study team. Responsible for timely and appropriate communication to the clinical operations team. Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety. Review progress of project and initiate appropriate actions to achieve target objectives assigned. CCTL-II is also the main point of contact for communication with the Global CTLs/PMS. Mentoring and training of new CCTL on Trip Report review processes as per ICH-GCP and SOPs and local Work Instructions. Performing quality check of work of new CCTL as a part of mentoring. Review and support development of training material and plans to support the training requirements of the department. Ensure training resources are up to date with changes in procedures. Support study team for CQC visits for local or regional clinical trial sites, if needed. Other duties as assigned by management: Ex Trip Report Template and guideline creation, Document Review, ETMF reconciliation, PD review and trending, PSV/SIV slide deck creation, CRA training, other CTL tasks.

Qualifications (Minimum Required): University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (e.g., Nursing Certification, Medical or Laboratory Technology). 10+ years of work experience in clinical research, including a strong working knowledge of ICHGCP guidelines and all other applicable guidelines and regulations. Trip Report review experience of minimum 2+ years is a must. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required): Minimum 2 years' experience in the job discipline: (inclusive of Trip Report review experience). Minimum 10+ years of clinical experience. Working knowledge of ICH GCP including internal regulatory requirements for the conduct of clinical development programs. Advanced computer skills (e.g., MS Office Suite - Word, Excel, PowerPoint presentation). Other required work-related experience: Act as an SME and lead initiatives. Thought leader in providing industry trends. Ability to negotiate/influence stakeholders/ others. Mentor Delivery teams and cross departmental synergies. Demonstrated ability to plan, prioritize, organize, and communicate effectively. Demonstrated ability to pay attention to detail. Strong interpersonal skills with ability to work well with others. Ability to deliver consistent high quality of work. Ability to use computer and departmental tools.

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