Associate Clinical Data Manager – Operations

This is a fully remote position, open to applicants in India.

📋 Description

• Collaborate with the Clinical Data Management team and internal project team members to deliver data management services for clients.

• Ensure timely and precise deliverables.

• Offer data management insights to internal project team members and clients.

• Communicate with internal project team members and clients regarding study data management activities.

• Draft data management documents.

• Conduct user acceptance testing on data management outputs.

• Facilitate and confirm data clarifications and modifications.

• Develop and sustain the Data Management Plan (DMP).

• Create and maintain study-specific Data Cleaning / Reconciliation reports and validation plans.

• Provide weekly data management status updates to clients and internal Project Managers.

• Collaborate with the internal Delivery team to establish data management timelines and ensure DM milestones are achieved.

• Create study-specific documentation manuals, including the Maintenance Guide (MG), as required.

• Conduct study-specific training sessions with internal Data Coordinators and Data Reviewers.

• Comply with Signant Health Standard Operating Procedures.

• Identify opportunities for process improvement in comprehensive Data Management.

• Engage in small group activities, kaizen events, and Lean Six Sigma projects when needed.

• Work a rotational night shift to support study and client requirements across time zones.

• Collaborate with clients and internal teams to create protocol-specific monitoring report specifications.

• Generate study-specific tools to flag discrepancies between client IVR/EDC and TrialManager outputs.

• Conduct protocol reviews and identify device design and eligibility criteria specific to the protocol.

• Define protocol-specific reports as necessary.

• Work together with the validation team to outline detailed test cases for clinically significant reports.

⛳️ Requirements

• BA/BS degree in a relevant discipline (Medicine, Statistics, Computer Science) or equivalent professional experience.

• Technical proficiency and capability to produce high-quality technical documentation.

• Understanding of and experience with HTML and various clinical databases.

• Exceptional attention to detail and organizational skills.

• Ability to rapidly learn and apply new skills, procedures, and methodologies.

• Capacity to meet very tight deadlines and handle multiple tasks in a highly dynamic work environment with minimal supervision.

• Ability to work both independently and within a team-oriented setting.

• A proactive and positive mindset towards tasks and projects.

• Proficient in Access, Excel, and other office software technologies and applications.

• Capability to manage multiple competing priorities with limited direct oversight.

• Strong verbal and written communication abilities.

• Willingness and capacity to work a night shift on a rotational basis.

• Familiarity with 21 CFR Part 11 or experience in a regulated setting.

• Over 3 years of professional experience in the clinical trials data management sector.

• Knowledge of data management best practices (GCP, GDPR, MHRA).

• Familiarity with EDC systems.

🏝️ Benefits

• Opportunity to engage with state-of-the-art AI technologies.

• Work that is meaningful and has a global impact.

• Innovation in clinical research and digital health.