<p><p><b>Description : 5 to 7 yrs<br/><br/>Work Mode : Hybrid (3 days in a week) / Onsite (for initial one or two months for training purpose from date of joining)<br/><br/>Work Location : White Field , Bangalore<br/><br/>Interview Process : 1st round - Virtual Tech Interview & 2nd Round ( Face to Face Technical interview @ ACL digital office {Whitefield / Bannerghatta })<br/><br/>CDM Mandatory Skills : End to end activities (Start, Conduct & Close), ECRF, Protocol Review, UAT testing, Data Cleaning, Discrepancy Management, Reconciliation<br/><br/><b>Job Description - Clinical Data Manager : </b><br/><br/><b>OVERVIEW : </b><br/><br/>The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases.
The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors.
The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.<br/><br/><b>KEY TASKS & RESPONSIBILITIES : </b><br/><br/>- Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.<br/><br/>- Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.<br/><br/>- Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.<br/><br/>- Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies.<br/><br/>- Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.<br/><br/>- Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.<br/><br/>Perform Query Management :</p><p><br/></p><p>- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities.<br/><br/>- Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.<br/><br/>- Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules.
</p><p><br/></p><p>- Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.<br/><br/>- Collaborate and work as a team to ensure the deliverables are completed on time with high quality.<br/><br/>- Ensure compliance with industry quality standards, regulations, guidelines, and procedures.<br/><br/>- Other duties as assigned.<br/><br/><b>CANDIDATES PROFILE : </b><br/><br/><b>Education & Experience : </b><br/><br/>- 5+ years experience in Clinical Data Management preferred.<br/><br/>- Bachelors degree in a health-related field or equivalent experience preferred.<br/><br/>- CCDM Certification preferred.<br/><br/><b>Professional Skills : </b><br/><br/>- Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.<br/><br/>- Strong analytical and strategic thinking skills<br/><br/>- Detail oriented, ability to multitask with strong prioritization, planning and organization skills.<br/><br/>- Excellent collaborative skills<br/><br/>- Demonstrated command of the English language with proficiency in both verbal and written communication<br/><br/><b>Technical Skills : </b><br/><br/>- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel<br/><br/>- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology<br/><br/>- Proficient with EDC and Clinical Data Management Systems<br/><br/>- Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.<br/><br/>- Experience with RBQM methodology preferred.<br/><br/>- Exposure to CDISC guidelines and standards</p><br/></p> (ref:hirist.tech)