Clinical Data Manager

Description : 5 to 7 yrsWork Mode : Hybrid (3 days in a week) / Onsite (for initial one or two months for training purpose from date of joining)Work Location : White Field , BangaloreInterview Process : 1st round - Virtual Tech Interview & 2nd Round ( Face to Face Technical interview @ ACL digital office {Whitefield / Bannerghatta })CDM Mandatory Skills : End to end activities (Start, Conduct & Close), ECRF, Protocol Review, UAT testing, Data Cleaning, Discrepancy Management, ReconciliationJob Description - Clinical Data Manager : OVERVIEW : 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.KEY TASKS & RESPONSIBILITIES : - Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.- Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.- Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.- Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies.- Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.- 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.Perform Query Management :- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities.- Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.- 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. - Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.- Collaborate and work as a team to ensure the deliverables are completed on time with high quality.- Ensure compliance with industry quality standards, regulations, guidelines, and procedures.- Other duties as assigned.CANDIDATES PROFILE : Education & Experience : - 5+ years experience in Clinical Data Management preferred.- Bachelors degree in a health-related field or equivalent experience preferred.- CCDM Certification preferred.Professional Skills : - Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.- Strong analytical and strategic thinking skills- Detail oriented, ability to multitask with strong prioritization, planning and organization skills.- Excellent collaborative skills- Demonstrated command of the English language with proficiency in both verbal and written communicationTechnical Skills : - Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology- Proficient with EDC and Clinical Data Management Systems- Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.- Experience with RBQM methodology preferred.- Exposure to CDISC guidelines and standards (ref:hirist.tech)