Clinical Data Management Specialist to Manager

Location: Kochi/Bangalore/Thane/Kolkata/Hyderabad/ Noida/Ahmedabad/Kochi

Experience: 2 to 15+ Years

Function: Clinical Data Management (CDM)

Work Mode: As per business/project requirements

Job Overview

We are looking for Clinical Data Management professionals across multiple levels, from Clinical Data Specialist to Clinical Data Management Manager, to support end-to-end clinical data management activities across global clinical studies.

The role will involve managing and delivering clinical data management activities across the complete study lifecycle, including study start-up, conduct and close-out, while ensuring data quality, timely delivery, compliance with applicable regulations/SOPs and customer requirements.

Candidates may be considered for different levels based on their experience, technical expertise, project leadership and client management capabilities.

Key Responsibilities

Manage and support end-to-end Clinical Data Management activities across global clinical studies.

Support/manage study start-up, conduct and close-out activities.

Perform comprehensive data review, data cleaning and resolution of data clarifications.

Support database design, database setup, validation and database revisions as applicable.

Work on Rave and other Clinical Data Management systems/tools.

Ensure quality, accuracy and timely delivery of CDM deliverables.

Prepare, review and maintain Data Management Plans (DMPs) and other project documentation.

Support data validation, reconciliation and management of external data/vendors as applicable.

Identify, investigate and resolve data issues, discrepancies and escalations.

Coordinate with Data Operations, Programming, Project Management and other cross-functional teams.

Participate in study kick-off meetings, sponsor meetings, internal/external audits and inspections as required.

Maintain effective communication with clients, sponsors and internal stakeholders.

Track project timelines, milestones, risks, issues and corrective actions.

Identify opportunities for process improvement, automation and new technology implementation.

Ensure compliance with Good Clinical Practices (GCP), regulatory guidelines, SOPs, work instructions and project-specific requirements.





Support training and mentoring of junior team members.

Client & Project Management For experienced candidates:

Act as a key/primary point of contact for clients on Data Management deliverables.

Independently manage multiple studies or large/global clinical trials.

Manage customer expectations, timelines, resources and deliverables.

Participate in client negotiations related to timelines, processes and resources.

Handle issue escalation and drive timely resolution.

Build and maintain strong customer relationships.

Participate in RFI/RFP, pricing discussions and bid defense activities as applicable.

Support project financial management, including budgets, forecasting, utilization, revenue recognition, invoicing and identification of out-of-scope activities.

Support proposals, scope of work and change-order management.

Leadership & People Management For Team Lead / Senior Team Lead / Manager levels:

Lead and mentor Clinical Data Management teams.

Manage resource allocation, workload planning and project staffing requirements.

Provide technical guidance and leadership to Data Team Leads and junior team members.

Conduct regular team meetings and monitor project status, timelines, quality and risks.

Identify training and career development requirements.

Drive employee engagement, process improvement and operational efficiency.

Establish and maintain effective communication across teams and senior management.

Develop and implement action plans for quality, productivity and process improvements.

Support development and maintenance of SOPs, work instructions and best practices.

Ensure appropriate coverage and continuity of project activities.

Technical & Functional Skills

Clinical Data Specialist 25 Years

25 years of core Clinical Data Management experience.

Experience in Rave/EDC and clinical data management activities.

Hands-on exposure to study start-up, conduct and close-out.

Ability to perform data review,



data cleaning, data clarification and quality control activities.

Ability to work independently with appropriate guidance.

Clinical Data Team Lead – 5–10 Years

5+ years of direct Data Management experience, with relevant project leadership exposure.

Experience managing end-to-end data management delivery.

Experience leading studies and handling clients/sponsors.

Strong understanding of clinical trial processes and DM lifecycle.

Experience with global/multiple studies preferred.

Strong stakeholder management and problem-solving skills.

Senior Data Team Lead – 8–12+ Years

Strong experience independently managing end-to-end Data Management delivery.

Experience managing multiple/global studies and large clinical trials preferred.

Strong client management, negotiation and escalation management skills.

Experience in project financial management, SOW/budget and RFP/bid defense activities.

Ability to provide technical leadership and mentor DTLs/DM professionals.

Experience as DTL, Program Lead, Customer Site Manager or SME is preferred.

Clinical Data Management Manager – 10–15+ Years

7+ years of relevant experience including people management, with advanced CDM expertise.

Strong leadership and team management experience.

Experience managing multiple projects, resources, timelines, financials and competing priorities.

Strong knowledge of clinical drug development and Data Management deliverables.

Ability to provide expert review/guidance on CRF/e-CRF, database design/setup, validation and DMPs.

Experience in proposals, RFP/RFI, bid defense, audits and inspections.

Strong business, operational and financial acumen.

Preferred Candidate Profile

Strong Clinical Data Management domain expertise.

Experience working on global clinical trials preferred.

Experience with large/complex studies preferred.

Strong Rave/EDC experience.

Excellent communication and stakeholder management skills.

Strong analytical, organizational and problem-solving abilities.

Ability to manage multiple priorities and work effectively in a matrix environment.

Strong client-facing and team leadership capabilities for senior positions.

Flexible to work according to project/shift requirements where applicable.

📌 Clinical Data Management (Ahmedabad)
🏢 Premier Consultants
📍 Ahmedabad