Clinical Data Manager

Worldwide Clinical Trials; Ernakulam; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Worldwide Clinical Trials is seeking a skilled Data Management professional to oversee start-up, conduct, and close-out activities across global projects. You will ensure DM activities stay on time and budget while delivering accurate data for sponsors.

You'll work with cross-functional teams, develop DM documentation, perform UAT, and drive process improvements. A bachelor's degree and 3+ years in clinical data management are required, with a track record of independently handling

Qualifications

• Bachelor's degree or higher in biomedical sciences, life sciences, computer science or related field.
• Minimum of 3 years of experience in clinical data management or a related role.
• Experience with data management processes in global trials (start-up, conduct, close-out).
• Strong written and verbal communication skills.
• Analytical and problem-solving abilities.
• Knowledge of protocols, SDTM and data handling standards.

Responsibilities

• Provide oversight of data management services across multiple global projects.
• Allocate resources to complete DM activities on time and within budget.
• Prepare DM trial documentation (DMP, DB specifications, edit check specifications).
• Ensure effective UAT is performed.
• Write external vendor reconciliation specifications for programming outputs.
• Oversee data cleaning activities and produce trial metrics.
• Ensure all database lock activities are completed on time.
• Represent Worldwide DM at internal and external study meetings.
• Monitor project scope, budgets and risks and alert DM Management.

Skills

Attention to detail

Written and verbal communication

Data management best practices

Cross-functional collaboration

Clinical trial processes

Analytical problem solving

Education

Bachelor's degree or higher in biomedical sciences / life sciences / computer science or related field

Job description

Job Description:

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

SUMMARY:

Provide expertise to data management assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor's satisfaction.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Provide oversight of data management services (start up, conduct and close out) across multiple complex global projects/programs, including:


• Ensure appropriate resources are allocated to complete all DM activities on time and budget.


• Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).


• Ensure effective UAT is performed.


• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).


• Oversee data cleaning activities.


• Produce metrics to monitor progress of trial activities.


• Ensure all database lock activities are completed on time.


• Represent Worldwide DM at both internal and external study meeting calls, including providing input.


• Monitor project scope, budgets and risks and alert DM Management of any concerns.


• Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g. during Project Review Meetings).


• Collaborate with internal Worldwide departments working on the same project.


• Provide feedback on process improvements to DM Management and/or SMEs.


• Participate in and lead process reviews.


• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

SKILLS:

• Excellent attention to detail.


• Excellent written and verbal communication skills.


• Working knowledge of data management best practices & technologies as applied to clinical trials.


• Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.


• Solid understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.


• Developing a analytical and problem solving skills.

REQUIREMENTS:

• Bachelor's degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.


• Min of 3 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.