JOB DESCRIPTION Job Title: Lead Data Manager Job Location: Bangalore Department: Clinical Data Management About Syngene: Syngene (<a href="http://www.syngeneintl.com">www.syngeneintl.com</a>) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Overall adherence to safe practices and procedures of oneself and the teams aligned</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Compliance to Syngene’ s quality standards at all times</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Hold self and their teams accountable for the achievement of safety goals </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Govern and Review safety metrics from time to time </li> </ul> Core Purpose of the Role: To lead and oversee clinical data management activities across clinical projects, ensuring high-quality, accurate, and compliant clinical trial data. The role is responsible for effective execution of data management processes, data quality oversight, team leadership, stakeholder engagement, process improvement, and compliance with regulatory and organizational standards. Role Accountabilities <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Execute and oversee data management activities for assigned clinical studies as Data Manager or Data Reviewer. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Review and contribute to Data Management Plans (DMPs). </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Perform quality checks on clinical data and identify data discrepancies. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Raise, track, and resolve data queries to ensure data accuracy and completeness. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Track CRFs (Case Report Forms) and query status throughout the study lifecycle. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Update resolved queries in databases for paper-based studies. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Ensure the quality, integrity, consistency, and completeness of collected and processed clinical data. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Provide inputs for proposal development and study feasibility assessments.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Support CRF design and review.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Provide inputs for edit check specifications and database validation requirements.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Generate and communicate periodic project and data management status reports.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Liaise with sponsors, investigators, and internal stakeholders to resolve data-related issues.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Coordinate with relevant departments to facilitate timely query resolution.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Partner with Quality Assurance (QA) teams during audits and inspections.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Oversee and support the daily functioning of the EDC Administration team.</li> </ul> Leadership Capabilities <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Lead, mentor, coach, and train data management team members. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Drive continuous improvement in data management processes and quality standards. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Ensure timely delivery of project milestones while maintaining compliance and data integrity. </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Monitor team performance and optimize resource utilization.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Lead audit preparedness activities and ensure adherence to SOPs and quality requirements.</li> </ul> Syngene Values All employees will consistently demonstrate alignment with our core values <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Excellence</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Integrity</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:150%;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Professionalism</li> </ul> Experience <ul style="margin-bottom:0.0cm;margin-top:8.0px"> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience in Clinical Data Management within Clinical Research, CRO or Pharmaceutical industries. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience managing Phase I–IV clinical trials, observational studies, and/or real-world evidence studies. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Proven experience in leading end-to-end data management activities, including study setup, database review, data cleaning, query management, and database lock. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience working with EDC systems, clinical databases, and data quality review processes. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience in client-facing roles with direct sponsor interactions and project governance participation. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Demonstrated experience in team leadership and mentoring. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience supporting audits, inspections, and regulatory compliance activities. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience in SOP development, process improvements, and departmental quality initiatives.</li> </ul> Skills and Capabilities <ul style="margin-bottom:0.0cm;margin-top:8.0px"> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Strong knowledge of Clinical Data Management processes and clinical trial data lifecycle.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience in CRF/eCRF design, edit check development, and database review.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Proficiency in query management, data cleaning, and data quality review.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Good understanding of EDC systems.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Knowledge of ICH-GCP, CDISC standards, and regulatory requirements.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Ability to prepare and review SOPs and quality-related documentation.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Strong project planning, tracking, and risk management skills.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Experience in managing multiple studies and meeting project timelines.\Excellent client communication and stakeholder management skills.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Strong written, verbal, and presentation skills.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Ability to collaborate effectively with cross-functional teams.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Proven leadership in mentoring, coaching, and developing team members.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Strong problem-solving, decision-making, and analytical skills.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Ability to drive operational excellence, quality, and compliance.</li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Demonstrates accountability, ownership, and a continuous improvement mindset.</li> </ul> Education <ul style="margin-bottom:0.0cm;margin-top:8.0px"> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Master's or Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Health Sciences, or a related discipline. </li> <li style="text-align:justify;line-height:150%;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Training or certification in ICH-GCP, regulatory compliance, and EDC systems is desirable.</li> </ul> Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Lead Data Manager - CDM (Bangalore, KA, IN, 560100) @ syngeneinternational

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