Centralised Clinical Team Lead

Job description

**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. **Physical Demands/Work Environment** - General Office environment. - Candidates may be homebased if business demands it. - Candidate should be able to work in shifts, if required and be ready to work extended hours. - May involve extensive use of computer and keyboard. - Some Domestic Travel may be required. Learn more about our EEO & Accommodations request here.