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Clinical Data Manager (CDM) Job Opening In Pune – Now Hiring Confidential


Job description

I.

Position Summary

The Senior Clinical Data Manager (CDM) is the Subject Matter Expert (SME) responsible for leading and executing all clinical data management activities from study startup through database lock.

This role ensures all deliverables meet the highest standards of quality, are completed on time and within budget, and comply with all Standard Operating Procedures (SOPs), current industry, and regulatory guidelines (ICH, GCP, GCDMP).

The CDM serves as the technical leader and primary contact for client and vendor communications.


II.

Key Responsibilities

A.

Study Leadership & Project Management

  • Independently manage the end-to-end delivery of Data Management services for single and multi-service clinical trial projects.


  • Serve as the primary liaison for internal teams, clients, and vendors, ensuring clear and effective communication throughout the study lifecycle.


  • Guide and mentor junior members of the Data Management team, including supervising and scheduling Data Management Associates.


  • Ensure data lock activities are performed according to agreed timelines, budget, and quality requirements.


B.

Database Design & Setup (Design Phase Expertise)

  • Serve as the technical expert for eCRF design, ensuring alignment with the study protocol and data management guidelines.


  • Lead the execution of all study plans, from Data Management Plan (DMP) development through to database lock.


  • Design, maintain, monitor, and lock databases for diverse trials, including Phase I (First-in-Human, PK/PD, SAD/MAD), Safety & Tolerability studies, utilizing various EDC systems.


  • Apply in-depth knowledge of CDISC CDASH standards during database design and mapping.


C.

Data Validation & Processing (Conduct Phase Expertise)

  • Oversee all data entry, data cleaning, and data transfer activities.


  • Implement and execute the Data Validation Plan (DVP) and create/maintain the Edit Check/Data Entry Guidelines (CCG/DEG) and Data Transfer Specifications (DTS).


  • Develop and validate SAS programs for data validation, and the creation of CDISC SDTM, ADaM, and Define-XML datasets.


  • Proactively identify and implement process improvements during study conduct (e.g., automating manual reconciliation processes like biomarker data checks) to improve efficiency and data quality.


D.

Closeout & Submission Readiness

  • Ensure all necessary activities are performed during the conduct phase to guarantee a smooth and timely database lock and closeout.


  • Prepare and finalize data export files as required for statistical analysis and submission.


  • Maintain audit-ready documentation and ensure complete traceability of all data management processes.


III.

Required Qualifications & Skills

A.

Experience

  • Minimum of 5 years of progressive experience in Clinical Data Management, with demonstrated ability to independently manage entire studies.


  • Proven experience working across all clinical trial phases, including Study Design, Conduct, and Closeout.


B.

Technical Expertise

  • Expert-level knowledge of all standard DM documents (DMP, DVP, CCG/DEG, DTS, Specs).


  • In-depth working knowledge of major EDC systems and study building processes.


  • Strong analytical, problem-solving, and technical skills in database programming (e.g., SQL, SAS).


  • In-depth knowledge of CDISC CDASH standards and their practical application in eCRF design and database build.


  • In-depth understanding of database structures.


C.

Regulatory & Soft Skills

  • In-depth knowledge of clinical trial processes, ICH, GCP, and GCDMP (SCDM) guidelines.


  • Proven ability to provide leadership and think strategically to achieve business goals.


  • Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines.


  • Excellent written and verbal communication skills.

Required Skill Profession

Mathematical Science Occupations


  • Job Details

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Unlock Your Clinical Data Potential: Insight & Career Growth Guide


Real-time Clinical Data Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Clinical Data in Pune, India, highlighting market share and opportunities for professionals in Clinical Data roles.

154810 Jobs in India
154810
4765 Jobs in Pune
4765
Download Clinical Data Jobs Trends in Pune and India

Are You Looking for Clinical Data Manager (CDM) Job?

Great news! is currently hiring and seeking a Clinical Data Manager (CDM) to join their team. Feel free to download the job details.

Wait no longer! Are you also interested in exploring similar jobs? Search now: .

The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Confidential adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying India laws and regulations

What Is the Average Salary Range for Clinical Data Manager (CDM) Positions?

The average salary range for a varies, but the pay scale is rated "Standard" in Pune. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

What Are the Key Qualifications for Clinical Data Manager (CDM)?

Key qualifications for Clinical Data Manager (CDM) typically include Mathematical Science Occupations and a list of qualifications and expertise as mentioned in the job specification. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

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Interview Tips for Clinical Data Manager (CDM) Job Success

Confidential interview tips for Clinical Data Manager (CDM)

Here are some tips to help you prepare for and ace your Clinical Data Manager (CDM) job interview:

Before the Interview:

Research: Learn about the Confidential's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.

Follow Up: Send a thank-you email to the interviewer within 24 hours.

Additional Tips:

Be Yourself: Let your personality shine through while maintaining professionalism.

Be Honest: Don't exaggerate your skills or experience.

Be Positive: Focus on your strengths and accomplishments.

Body Language: Maintain good posture, avoid fidgeting, and make eye contact.

Turn Off Phone: Avoid distractions during the interview.

Final Thought:

To prepare for your Clinical Data Manager (CDM) interview at Confidential, research the company, understand the job requirements, and practice common interview questions.

Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Confidential's products or services and be prepared to discuss how you can contribute to their success.

By following these tips, you can increase your chances of making a positive impression and landing the job!

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