Job Opportunities API

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. Learn more about our EEO & Accommodations request here .