Senior Process Lead

<h2>Job Overview:</h2><p style="margin: 0px;">Follow applicable departmental standard operating procedures and work instructions</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Complete required trainings according to required timelines.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Manage day-to-day tasks ensuring quality and productivity.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Create and modify clinical investigator manuals, requisitions and other relevant materials</span></p><p style="margin: 0px;">according to SOW requirements to provide on-time, quality project related documentation</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Provide administrative and technical support to internal departments as needed.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ensure that assigned project related documents are completed in a timely manner.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Work effectively with internal departments to ensure delivery of appropriate documentation</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Perform QC reviews of related department specific documents wherever applicable in the</span></p><p style="margin: 0px;">process. Also Peer QC review when required</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ensure timely escalation and issue resolution</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to mentor, coach and train junior members/new joiners of the department.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Proactively identifies opportunities for process improvements. Leads the process</span></p><p style="margin: 0px;">improvement opportunities and manages the implementation of associated revised processes</p><p style="margin: 0px;">and procedures.</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Perform investigations independently on reported quality events and able to perform Root</span></p><p style="margin: 0px;">cause analysis and write CAPA statements</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Timely documentation of operational/training metrics and provide data on the same as per</span></p><p style="margin: 0px;">management request</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Perform Metrics trend analysis for the team and provide inputs on performance</span></p><p style="margin: 0px;">improvement as applicable</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Preparation, maintenance and updating of Training Plan</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Reviews and makes changes to department controlled documents</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Acts as the departmental liaison for other department</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Hold periodic remediation trainings for the team or identified members based on the trend</span></p><p style="margin: 0px;">analysis received/discussed from/with peers and management</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Support supervisor in managing operations of the team</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">To act as back up for the line manager of the team wherever applicable per directions from</span></p><p style="margin: 0px;">management</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Be a part of Internal and External Audits wherever applicable</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Other duties as assigned by management</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Should be able to provide training on all technical tools used within the department as</span></p><p style="margin: 0px;">applicable</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Bachelor’s /Master’s Degree</p><h2>Experience:</h2><p style="margin: 0px;">4 years in a relevant industry.</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Demonstrated ability to plan, prioritize, organize and communicate effectively.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Demonstrated ability to pay attention to detail.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Strong interpersonal skills with ability to work well with others.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to deliver consistent high quality of work.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to use computer and departmental tools.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to Influence others.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to facilitate meetings.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to support the team manager in providing oversight on daily operational</span></p><p style="margin: 0px;">deliverables for the team and the necessary documentation on the same</p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to lead process improvement initiatives.</span></p><p style="margin: 0px;"><span style="font-size: medium;"> </span><span style="font-size: medium;">Ability to train others</span></p>