Centralized Trip Report Reviewer (Clinical Operations)

<h2>Job Overview:</h2><p style="margin: 0px;">Job location: Homebased, India</p><p style="margin: 0px;"> </p><ol><li style="color: black;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Management of complex projects under direction of a Project Manager / Director as assigned.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ensure site monitoring responsibility for clinical studies are conducted according to Covance Standard Operating Procedures, ICH Guidelines and GCP.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned (Implementation of Initiatives either independently or with team)</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Proactively identifies opportunities for process improvements and work collaboratively with project team incase further action required</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Complete required trainings according to required timelines.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Follow applicable departmental Standard Operating Procedures and Work Instructions.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Proactively identifies opportunities for process improvements. Lead the process improvement opportunities and manage the implementation of associated revised processes and procedures.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Responsible for the timely and appropriate communication to the clinical operations team</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Review progress of project and initiate appropriate actions to achieve target objectives assigned.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">TRRII is also the main point of contact for communication with the Global CTLs/PMs.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Mentoring and training of new TRRs on trip report review processes as per ICH-GCP and in house SOPs and local work instructions</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Performing quality check of the work ofnew TRRs as a part of mentoring.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Review and support development of training material and plans to support the training requirements of the department.</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ensure training resources are kept up to date with changes in procedures</span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Other duties as assigned by management: Ex- Document Review, ETMF reconciliation, other CTL tasks etc.</span></li></ol><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience:</span></p><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Years of experience in the job discipline: 00-02 Years (inclusive ofTRR experience)</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Years of experience in other professional roles: 10+ Years</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Other required work-related experiences:</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Act as an SME and lead initiatives</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Thought Leader in providing Industry trends</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to Influence stakeholders</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Mentor Delivery teams and cross departmental synergies of 4</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Demonstrated ability to plan, prioritize, organize and communicate effectively.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Demonstrated ability to pay attention to detail.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Strong interpersonal skills with ability to work well with others.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to deliver consistent high quality of work.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to use computer and departmental tools.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Strong interpersonal skills.</span></li><li><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to negotiate/lnfluence with others.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0in 0in 7.85pt 0.15in;">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 10+ 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 us must.</p><p style="margin: 0in 0.25pt 11.25pt 10.55pt;">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.</p><h2>Experience:</h2><p style="margin: 0in 0in 0pt 0.45pt;"><span style="font-size: 11pt;">Minimum Required:</span></p><ul><li><span style="font-size: 8pt;">Years of experience in the job discipline: 00-02 Years (inclusive ofTRR experience)</span></li><li><span style="font-size: 8pt;">Years of experience in other professional roles: 10+ Years</span></li><li><span style="font-size: 8pt;">Other required work-related experiences:</span></li><li><span style="font-size: 8pt;">Act as an SME and lead initiatives</span></li><li><span style="font-size: 8pt;">Thought Leader in providing Industry trends</span></li><li><span style="font-size: 8pt;">Ability to Influence stakeholders</span></li><li><span style="font-size: 8pt;">Mentor Delivery teams and cross departmental synergies of 4</span></li><li><span style="font-size: 8pt;">Demonstrated ability to plan, prioritize, organize and communicate effectively.</span></li><li><span style="font-size: 8pt;">Demonstrated ability to pay attention to detail.</span></li><li><span style="font-size: 8pt;">Strong interpersonal skills with ability to work well with others.</span></li><li><span style="font-size: 8pt;">Ability to deliver consistent high quality of work.</span></li><li><span style="font-size: 8pt;">Ability to use computer and departmental tools.</span></li><li><span style="font-size: 8pt;">Strong interpersonal skills.</span></li><li><span style="color: black; font-family: 'Times New Roman',serif; font-size: 8pt;">Ability to negotiate/lnfluence with others.</span></li></ul>