PHARMAFull-time
Associate Clinical Data Manager
By Admin · Clinical Data Management
BANGALORE (IN)REMOTEPOSTED: 9/3/2026
PHARMAFull-time
HIRING ORGANIZATIONFORTREAContract Research Organization (CRO) / Biosciences / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Job Overview & Leadership Scope
Provide Data Management leadership for assigned clinical studies and assume responsibility for end-to-end Data Management activities from study start-up through database lock.
Lead the development of project documentation, data-management procedures, data-entry processes and data-validation processes.
Provide direction and assign appropriate Data Management activities to more junior team members.
Ensure clinical data-management deliverables meet client quality expectations while remaining within agreed project timelines and budgets.
Work directly with Sponsors to understand their specific requirements and lead implementation of those requirements.
Regularly review client-specific processes to ensure they remain effective and appropriate for both Sponsor and Fortrea requirements.
Study Leadership & Delivery
Lead clinical studies involving healthy volunteers and patient populations.
Manage multi-site studies and projects requiring direct client management.
Support studies with standard or reduced timelines.
Organize, prioritize and manage workload and project deliverables effectively.
Take accountability for all assigned Data Management deliverables according to established timelines.
Provide instructions and operational guidance to Data Management study teams.
Review study-team output to ensure high-quality clinical data-management deliverables.
Adjust resource allocation when required to support project priorities and delivery timelines.
Data Management Project Planning
Lead Data Management activities from study initiation through database lock.
Develop and maintain project Data Management documentation.
Support system setup according to protocol, client and project requirements.
Define and oversee data-entry procedures.
Define and oversee data-validation procedures and processes.
Ensure Data Management activities are planned and coordinated with project milestones.
Maintain accurate records of all work undertaken.
Quality, Protocol & GCP Compliance
Ensure allocated projects are conducted according to applicable clinical study protocols.
Follow global harmonized Standard Operating Procedures.
Ensure activities meet specified Good Clinical Practice standards.
Maintain clinical data quality and integrity according to client requirements.
Support compliant and controlled execution of Data Management activities throughout the study lifecycle.
Ensure study-team outputs meet expected quality standards.
Project Timeline & Milestone Management
Work closely with Project Managers to develop project timelines.
Support planning required to achieve contracted project milestones.
Communicate with functional leads across multiple disciplines.
Participate in study initiation meetings and other required project-planning activities.
Monitor progress against established timelines.
Identify potential timeline risks and communicate impacts to relevant stakeholders.
Support mitigation planning to protect key deliverables and database-lock dates.
Data Management Team Leadership
Provide leadership and accountability for the Data Management project team.
Lead data-focused internal project-team meetings.
Coordinate Data Management activities with relevant study functions.
Provide direction to team members and monitor deliverable quality.
Support efficient workload allocation across Data Management study teams.
Mentor and coach internal team members on Data Management and clinical-trial processes.
Provide constructive feedback to support career development, interpersonal effectiveness and achievement of competency standards.
Support Data Management managers with performance evaluation of team members.
Cross-Functional Biometrics Collaboration
Work closely with study leads in Electronic Data Capture Design.
Coordinate with SAS Programming teams.
Collaborate with Statistics teams.
Coordinate with Pharmacokinetics teams.
Participate in cross-functional planning to ensure deliverables are aligned and coordinated.
Maintain awareness of deliverables across other Biometrics functional groups.
Understand cross-functional dependencies affecting Data Management timelines, resources and deliverables.
Support risk and mitigation strategies involving Biometrics functions.
Consult with Project Managers, designated representatives and functional-group management when required.
Risk Management & Database Lock Readiness
Proactively identify potential project and Data Management risks.
Develop and support appropriate mitigation strategies.
Lead data-focused discussions to address risks affecting study delivery.
Communicate data-driven issues effectively to support achievement of database-lock timelines.
Monitor dependencies and risks affecting Data Management deliverables.
Keep Project Managers informed of project progress and potential delivery issues.
Support planning and coordination required for timely database lock.
Sponsor & Client Management
Work directly with Sponsors to understand project-specific requirements.
Develop and maintain effective client relationships.
Support implementation of Sponsor requirements within project processes.
Review client satisfaction surveys and support actions based on feedback.
Keep Project Managers and relevant Sponsor-facing teams informed of significant project information.
Communicate relevant Sponsor requirements, project changes and potential impacts to the appropriate internal stakeholders.
Handle and support resolution of customer concerns.
Address client comments with the study team and ensure appropriate follow-up.
Scope, Budget & Change Management
Track changes to project scope.
Work with Project Managers to ensure Sponsor approval is obtained for scope changes.
Support processing of approved scope changes.
Communicate budget status and relevant project financial information to appropriate stakeholders.
Identify and communicate work-scope changes and timeline impacts.
Support management of project requirements within agreed budgets and contracted milestones.
Clinical Data Reconciliation & Data Integration
Perform reconciliation of the clinical database against safety data.
Reconcile clinical data against laboratory data when required.
Perform reconciliation against other third-party data sources as appropriate.
Use local laboratory systems where applicable.
Utilize batch data-load facilities where appropriate.
Support consistency, completeness and integrity across clinical and external data sources.
Technology & Process Improvement
Maintain accountability for learning new Data Management technologies.
Keep current with evolving Data Management processes and industry technologies.
Assess industry-wide technology developments and feasibility for operational improvement.
Support continuous process improvement within Fortrea.
Apply relevant new technologies and processes to improve Data Management efficiency and effectiveness.
Audits & Issue Resolution
Represent Data Management during client and internal audits when required.
Attend and support audit activities.
Action audit findings and assigned follow-up activities.
Resolve identified issues within appropriate timelines.
Address client comments and concerns in collaboration with the study team.
Support continuous compliance and quality improvement through effective issue management.
Business Development & Biometrics Representation
Represent Data Management and, where required, the broader Biometrics function in new-business opportunities.
Support communication of Data Management and Biometrics capabilities.
Actively promote Biometrics services to Sponsors when appropriate.
Contribute technical and operational expertise during business-development activities.
Qualifications
University or college degree required.
Relevant and equivalent professional experience may be considered in lieu of formal educational requirements.
A combination of education and relevant work experience equivalent to a bachelor's degree may be accepted.
Fluency in English is required, including written and verbal communication.
Experience Requirements
Requires 6 to 8 years of Data Management experience.
Requires a minimum of 1 year of direct Sponsor-management experience.
Experience managing customer concerns is preferred.
Experience managing Scope of Work and project budgets is preferred.
Requires knowledge of clinical-trial processes.
Requires knowledge of Clinical Data Management.
Requires familiarity with Clinical Operations and Biometrics.
Requires knowledge of relevant system applications supporting clinical operations.
Requires knowledge of medical terminology.
Preferred Qualifications
Degree in Life Sciences, Health Sciences, Information Technology or a related discipline is preferred.
Scientific knowledge or a scientific background is preferred.
Thorough knowledge of Fortrea, its organizational structure and Standard Operating Procedures is preferred.
Three or more years of Electronic Data Capture experience is preferred.
Professional & Leadership Competencies
Strong project and time-management abilities.
Ability to meet project productivity metrics and deadlines.
Strong organizational skills.
Good written and verbal communication.
Strong interpersonal skills.
Effective teamwork and collaboration capabilities.
Ability to lead teams without compromising quality or timelines.
Ability to manage competing priorities and project risks.
Ability to communicate effectively with Sponsors and cross-functional stakeholders.
Work Environment
Remote role associated with the Bangalore location.
Work may be performed in an office and/or home-based environment.
May require overtime based on project requirements.
May require weekend work when required.
Candidates should be willing to work flexible shifts according to business requirements.
REQUIRED VERIFIED SKILLS
Clinical Data Management
Clinical Trial Management
Data Management Leadership
Study Start-Up
Database Lock
Clinical Data Quality
Data Validation
Data Entry Procedures
Project Documentation
Clinical Study Protocols
SOPs
GCP
Sponsor Management
Client Management
Project Timeline Management
Resource Allocation
Risk Management
Electronic Data Capture
EDC Design
SAS Programming Coordination
Statistics Coordination
Pharmacokinetics Coordination
Biometrics
Clinical Data Reconciliation
Safety Data Reconciliation
Laboratory Data Reconciliation
Third-Party Data Reconciliation
Batch Data Loading
Clinical Operations
Scope Management
Budget Management
Change Management
Audit Management
Medical Terminology
English Communication
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Salary information is not disclosed in the provided official job posting. Compensation for this senior Clinical Data Management role is expected to depend on years of Data Management experience, direct Sponsor-management experience, leadership responsibilities, EDC expertise, project complexity and overall Biometrics experience. Candidates should confirm the complete compensation package during the recruitment process, including fixed salary, performance incentives, health and insurance benefits, retirement benefits, paid leave, remote-work arrangements and any additional total-rewards components. Candidates with experience managing budgets, scope changes, Sponsors and cross-functional study teams may have stronger positioning when discussing compensation.
ORGANIZATION CONTEXT & CULTURE
Fortrea is a global contract research organization (CRO) providing comprehensive clinical development, patient access, and laboratory services. Spun off from Labcorp in 2023, Fortrea partners with pharmaceutical, biotech, and medical device companies to accelerate the development and commercialization of new therapies. They offer a full suite of services across the entire drug development lifecycle.
TEAM SIZE: 19,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Biosciences / Healthcare
EXPECTED CAREER ROADMAP
This role provides a significant leadership pathway within Clinical Data Management and Biometrics. With strong performance, professionals can progress toward Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Associate Director or Director-level Data Management and Biometrics leadership roles. The position develops broad experience across Sponsor management, project delivery, database lock, team leadership, budget and scope management, risk mitigation and cross-functional Biometrics coordination. Direct collaboration with EDC Design, SAS Programming, Statistics, Pharmacokinetics and Clinical Operations can create opportunities to move into broader clinical development leadership, data strategy, clinical systems, biometrics operations or global project management roles. Professionals who develop strong strategic, people-leadership and Sponsor-management capabilities can advance into senior operational and functional leadership positions.
APPLICATION ADVISORY
Tailor your resume to demonstrate end-to-end ownership of Clinical Data Management activities from study start-up through database lock. Clearly quantify your experience leading studies, managing Data Management teams, interacting directly with Sponsors and delivering projects within timelines and budgets. Highlight experience with EDC, clinical database reconciliation, safety and laboratory data reconciliation, scope changes, risk management and audit support. Include examples of coordinating with SAS Programming, Statistics, Pharmacokinetics, Clinical Operations and other Biometrics functions. Prepare for interviews by reviewing GCP, Data Management lifecycle activities, database-lock readiness, Sponsor communication and project risk mitigation. Be prepared to provide specific examples of resolving timeline risks, managing difficult client concerns, handling scope changes, mentoring team members and balancing data quality with project deadlines and budgets.
RECOMMENDED TRAINING
1/5
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