2,150 Clinical Data Manager jobs in India

Role Overview

The Clinical Data Manager is responsible for collaborating with the Clinical Data Management team and other internal stakeholders to deliver accurate, high-quality, and timely data management services for customers. This role provides expert guidance on data management activities, authors study-specific documents, ensures compliance with standards, and drives continuous improvement in processes and deliverables.

Key Accountabilities:

• Collaborate across functional groups to resolve technical issues impacting data quality and support technical initiatives within Data Management.
• Provide data management guidance to internal project team members and customers.
• Communicate effectively with internal stakeholders and customers on all aspects of study-specific data management activities.
• Author Data Management Plans (DMPs) and Data Transfer Specifications (DTS).
• Perform user acceptance testing (UAT) on reports and automated data checks used in data cleaning activities.
• Review, evaluate, and act on outputs from automated data checks.
• Facilitate risk assessments for mid-study changes.
• Verify data extracts against DTS requirements.
• Provide proactive data monitoring as per contractual obligations.
• Facilitate and verify data clarifications, corrections, and external data reconciliation.
• Contribute to process improvements that reduce timelines, increase quality, mitigate risks, and enhance overall team performance.
• Ensure effective communication within multidisciplinary project teams to meet deadlines and budgets.
• Assist in developing and enhancing Standard Operating Procedures (SOPs), Working Instructions, and Best Practices.

KNOWLEDGE, SKILLS & ATTRIBUTES

Essential:

• BA/BS degree in Medicine, Statistics, Computer Science, or a related field (or equivalent experience).
• Strong verbal and written communication skills.
• Ability to produce high-quality technical documentation.
• Excellent attention to detail and organizational skills.
• Quick learner with ability to adapt to new procedures, tools, and approaches.
• Proven ability to meet tight deadlines and manage multiple priorities in a fast-paced environment with minimal supervision.
• Effective collaborator with a strong ability to work both independently and as part of a team.
• Positive, proactive, and adaptable approach to tasks, projects, and process changes.

Desirable:

• 5+ years of professional experience in clinical trial data management.
• Experience in providing data management services within the clinical trials industry.
• Proficiency in MS Access, Excel, and related office software applications.
• Ability to manage multiple competing priorities under minimal supervision.
• Familiarity with 21 CFR Part 11 or experience in a regulated environment.

DECISION MAKING AND INFLUENCE

• Participate in data-related special projects and departmental initiatives.
• Mentor and support less experienced staff, ensuring adherence to project-specific and standardized data management processes.
• Represent Clinical Data Management during client meetings, audits, inspections, and bid defenses.

We know that everyone has different wants and needs, which is why along with a highly competitive base salary we support our people and their loved ones with a variety of perks and benefits. As part of our team some of the benefits you can expect to receive are:

• Medical Insurance, Group Accidental Coverage/Insurance, Group Term Life Insurance
• Company Paid Subscription to Calm – The #1 app for mental fitness.
• Employee Referral Program – Bring the Best to Signant Health and earn a reward.
• Wellness Program – Participate in challenges and earn points for rewards.
• Proof – Signant's Employee Recognition Program where you can accumulate points to redeem
• exciting merchandise, gift cards, tickets, and more.
• Burn Along – Digital fitness and wellness platform

Does this sound like something you'd like to explore? Then we'd love to hear from you

To apply, please submit your CV and a cover letter letting us know why you think you'd be perfect for this role. We will begin reviewing submissions during the application period and will fill the vacancy as soon as a suitable candidate is identified.

At Signant Health, accepting difference isn't enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

Roles and Responsibility

• Manage and oversee the development and implementation of clinical data management systems.
• Ensure compliance with regulatory requirements and industry standards for clinical data management.
• Collaborate with cross-functional teams to identify and prioritize project requirements.
• Develop and maintain data quality control processes to ensure accuracy and integrity of clinical data.
• Provide training and support to staff on clinical data management systems and procedures.
• Analyze and resolve complex data-related issues and discrepancies.

Job Requirements

• Strong knowledge of clinical data management principles and practices.
• Experience with Veeva EDC is highly desirable.
• Excellent analytical and problem-solving skills with attention to detail.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Strong understanding of regulatory requirements and industry standards for clinical data management.

Experience:
5+ yrs

Work Mode:
Work from Office

Work Location:
Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY

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.

CANDIDATE'S PROFILE:

Education & Experience

• 5+ years' experience in Clinical Data Management preferred.

• Bachelor's 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

• Tasks have been carried out independently and the status is communicated back to all relevant parties.

• Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications

• Configure, QC, and Test Study EDT and obtain client sign off on approved DTS.

• Ensure EDT is delivered in accordance with the required frequency and specifications.

• Control the receipt and integration of partner or 3PL data, as per scope of study.

• Perform data reconciliations within the context of the assigned team, (and service), as appropriate to ensure a clean data set.

• Perform approved data cleaning functions in order to maintain a clean data set.

• Adherence to all written and authorized SOPs and/or work instructions.

• Understand data structures, e.g, CDISC, LOINC

• Experience of SAS programming to produce derived analysis datasets.

• Collaborate with internal departments to make sure data is collected, managed and reported clearly, accurately and securely.

• Support client and internal audits.

• Takes on mentoring newer Data Management team members.

Roles and Responsibility

• Manage and oversee the development, implementation, and maintenance of clinical databases.
• Ensure data quality, accuracy, and compliance with regulatory requirements.
• Collaborate with cross-functional teams to design and implement data-driven solutions.
• Develop and maintain data standards, guidelines, and best practices.
• Provide training and support to staff on data management systems.
• Identify and mitigate risks associated with data management.

Job Requirements

• Strong knowledge of clinical data management principles and practices.
• Experience with clinical trial conduct and regulatory requirements.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Familiarity with data management software and tools.

• Oversee the design and development of clinical databases, including data structures, edit checks, and data validation plans.
• Manage the end-to-end data management process for clinical trials, from database setup to database lock.
• Develop and maintain data management plans (DMPs) in accordance with study protocols and company standards.
• Perform data cleaning activities, identify data discrepancies, and work with sites to resolve them.
• Generate data management reports, including progress reports and data metrics.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements (e.g., FDA, EMA), and internal SOPs.
• Collaborate with biostatisticians and programmers to define data analysis specifications and support statistical reporting.
• Oversee the quality control of data management activities performed by external vendors or internal teams.
• Participate in the selection and implementation of clinical data management systems (CDMS) and EDC tools.
• Contribute to the training of clinical site staff on data entry requirements and procedures.
• Archive all relevant data management documentation.

• Bachelor's degree in a scientific or healthcare-related field (e.g., Biology, Pharmacy, Statistics, Computer Science).
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial processes and data flow.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, IBM Clinical).
• Knowledge of clinical data standards (e.g., CDISC SDTM, ADaM) is highly preferred.
• Familiarity with GCP guidelines and regulatory requirements for clinical data.
• Excellent attention to detail, organizational skills, and ability to manage multiple tasks simultaneously.
• Strong analytical and problem-solving skills.
• Effective communication and interpersonal skills for remote collaboration.
• Proficiency in database management and data validation principles.
• Ability to work independently and proactively in a fully remote environment.