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.
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