Job Description

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