Clinical Data Manager

2 days ago

Bengaluru, Karnataka, India MindSource Technologies Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Description :


Experience : 5 to 7 yrs

Work 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 , Bangalore

Interview 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, Reconciliation

Job 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 :

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 communication

Technical 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

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