Role- Associate Team Lead

Department- Clinical Data Management

Reporting to- Senior Manager - Clinical Research Operations

Location- Pune ( Office – Based )

About ProRelix Research

ProRelix Research is clinical research organization (CRO) providing end-to-end clinical research services to global clients. The company specializes in areas such as clinical data management, biostatistics, medical writing, and regulatory support. ProRelix is committed to delivering high-quality, compliant, and efficient solutions across the clinical research lifecycle.

ProRelix Research is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive workplace for all employees, regardless of gender, background, age, or belief.

Website: www.prorelixresearch.com

Role Purpose To lead and manage all clinical data management activities across multiple clinical trials, ensuring high-quality, compliant, and timely delivery of data in accordance with regulatory requirements, SOPs, and project specifications.

Detailed Responsibilities

- Lead end-to-end clinical data management activities from study start-up to database lock and closeout
- Act as the single point of contact for multiple studies, coordinating with clients and cross-functional teams (Biostatistics, Programming, Medical, Safety, QA, Vendors)
- Ensure preparation, review, and maintenance of all clinical data management documents (DMP, CRF Completion Guidelines, Validation Plans, etc.)
- Manage client communication regarding timelines, deliverables, and project updates
- Maintain study files in an audit-ready state at all times
- Allocate, monitor,



and review tasks for data management team members to ensure quality and timeline adherence
- Collaborate with internal stakeholders and functional leads to ensure smooth project execution
- Serve as escalation point for unresolved data issues and ensure timely resolution
- Ensure appropriate resource planning and allocation across projects
- Ensure compliance with DMP, SOPs, and contractual obligations (SOW)
- Implement and oversee quality management plans; track performance and drive corrective actions
- Identify opportunities for process improvement and lead implementation initiatives
- Train, mentor, and develop team members in data management and medical coding
- Coordinate with third-party vendors (CDMS, medical coding dictionaries, labs, etc.)
- Ensure data accuracy, reliability, and readiness for analysis and regulatory submission
- Oversee CRF design, database development, edit checks, UAT, and medical coding processes
- Supervise data cleaning, reconciliation, query management, and interim data reviews
- Manage database freeze, lock, and archival activities

Key Result Areas (KRAs)

- Data quality and integrity
- Project timeline adherence
- Audit and inspection readiness
- Team productivity and task management
- Client satisfaction
- Compliance with SOPs and regulatory standards





Key Performance Indicators (KPIs)

- ≥ 98% data accuracy with minimal queries/rework
- ≥ 95% milestones delivered within agreed timelines
- 0 critical audit findings, minimal minor observations
- ≥ 95% task completion within timelines
- High client satisfaction scores / repeat business
- 100% compliance with SOPs, GCP, and regulatory requirements

Functional Competencies

- Strong knowledge of Clinical Data Management processes
- Expertise in CDMS systems and database design
- Understanding of CDISC/CDASH standards
- Data cleaning, query management, and reconciliation expertise
- Knowledge of clinical trial lifecycle and drug development
- Proficiency in MS Office and project management tools

Behavioural Competencies

- Leadership and team management
- Strong communication and stakeholder management
- Problem-solving and decision-making ability
- Attention to detail and quality focus
- Ability to manage multiple projects
- Mentoring and coaching mindset

Educational Qualification

- Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or related field
- Master’s degree or certifications (e.g., Clinical Research, PMP) preferred

Experience

- 5+ years of experience in Clinical Data Management

Professional Growth & Career Advancement

This role offers leadership exposure in managing complex global clinical trials and cross-functional teams. Employees can progress to senior leadership roles such as Senior Manager – Clinical Data Management, Program Lead, or Head of Data Management based on performance and organizational needs.

📌 Associate Team Lead - Clinical Data Management (Maharashtra)
🏢 ProRelix Research
📍 Maharashtra