Centralized Trip Report Reviewer I
Essential Job Duties:
- Management of projects under direction of a Project Manager / Director as assigned.
- Ensure site monitoring responsibility for clinical studies are conducted according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
- Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned (Implementation of Initiatives either independently or with team)
- Proactively identify opportunities for process improvements and work collaboratively with project team incase further action required
- Complete required trainings according to required timelines.
- Follow applicable departmental Standard Operating Procedures and Work Instructions
- Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for 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
- Responsible for the 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.
- Support in review of Standard Operating Procedures or Work Instructions to align with process or tool modifications
- Other duties as assigned by management: Ex: Document Review, ETMF reconciliation, other CTL tasks etc.
University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 07-09 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations. Exclusive
Trip Report Review experience of 02 years is ideal. In Lieu of this requirement, candidates with 05 or more years of relevant clinical research experience in Pharmaceutical or CRA industries may be considered.
In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.
- Years of experience in the job discipline: 00-02 Years
- Years of experience in other professional roles: 07-09 Years
- Other required work-related experiences:
- 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.
- Strong interpersonal skills.
- Ability to Influence and Lead.
- Ability to facilitate meetings.
- Ability be part of process improvement initiatives.