Clinical Data Manager -II at Allucent

Chennai, tamil nadu, India -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical data management, EDC training, Database setup, eCRF design, Data validation, Data cleaning, User acceptance testing, Protocol review, Data reconciliation, Project management, Clinical programming, Data integrity, Regulatory compliance, Risk management, Vendor management

Industry

Pharmaceutical Manufacturing

Description

Support DM-related activities and collaborate with Lead DMs, Clinical Programmers, Data Scientists, Clinical Monitoring teams, and other functions like Project Management, Clinical Operations, and Biostatistics • Provide regular updates to Lead DM on progress, timelines, risks, and quality; support resource planning when assigned as Lead CDM • Track tasks against budget and forecasts; identify and initiate scope change requests when required • Develop, review, and maintain key DM documents such as DMP, eCRF specifications, DVP, and external data transfer agreements • Support or lead clinical database setup, including eCRF design and validation requirements • Participate in reviewing study documents like protocols, project plans, safety plans, and statistical analysis plans • Coordinate and complete User Acceptance Testing (UAT) activities for databases Create training materials and provide EDC training for study teams • Review and validate clinical data to ensure accuracy, consistency, integrity, and completeness • Support data cleaning strategies and assist in data releases (interim, final locks, and post-lock updates) • Perform and coordinate data transfers and reconciliation activities (SAE, PK, lab data, etc.) • Prepare and review project metrics and status reports, highlighting site performance, data trends, and protocol deviations • Support and conduct Quality Review activities; may also lead these when required • Support or manage database maintenance, lock, and close-out activities • Participate in meetings with vendors and sponsors as needed • Identify issues, solve problems, and assess effectiveness of solutions • Maintain up-to-date DM documentation and ensure proper filing throughout the study • Prepare documentation for audits and participate in internal/external audits when assigned • Support alignment of data management and clinical programming standards and best practices • Contribute to process improvement initiatives to enhance efficiency Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

Responsibilities

The Clinical Data Manager II supports data management activities, including database setup, eCRF design, and data validation to ensure integrity and consistency. They also collaborate with cross-functional teams to manage study timelines, budgets, and documentation while ensuring compliance with clinical standards.