Associate Clinical Data Manager – Operations

🔥 10 hours ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 12%

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Signant Health

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2000

🏥 Healthcare

☁️ SaaS

💰 Private equity on 2018-08

Healthcare • SaaS

Signant Health is a provider of eClinical technologies and services focused on collecting, managing, and analyzing clinical trial data. The company offers a suite of solutions including electronic Clinical Outcome Assessment (eCOA/ePRO), Electronic Data Capture (EDC), unified eClinical platform, eClinician ratings, rater training, randomized trial supply management (RTSM) and supply chain software, digital health technologies (telemedicine, eConsent, patient engagement apps), COA data analytics, data aggregation and intelligence, and clinical consulting services. They serve sponsors, CROs, biotech, medical devices, and other clinical trial stakeholders, supporting global trials and regulatory submissions. Signant emphasizes scientific expertise, with in-house scientists and clinicians, protocol design support, and experience across therapeutic areas including CNS, oncology, pediatrics, vaccines, and psychedelics. The company highlights 30 years of experience and involvement in trials linked to a significant portion of recent novel drug approvals.

📋 Description

• Work with the Clinical Data Management team and internal project team members to provide data management services for customers • Ensure on-time and accurate deliverables • Provide data management guidance to internal project team members and customers • Communicate with internal project team members and customers on study data management activities • Author data management documents • Perform user acceptance testing on data management deliverables • Facilitate and verify data clarifications and data changes • Develop and maintain the Data Management Plan (DMP) • Develop and maintain study-specific Data Cleaning / Reconciliation reports and validation plans • Provide weekly data management status updates to clients and internal Project Managers • Work with the internal Delivery team to define data management timelines and ensure DM milestones are met • Develop study-specific documentation manuals, including the Maintenance Guide (MG), as necessary • Conduct study-specific trainings with internal Data Coordinators and Data Reviewers • Adhere to Signant Health Standard Operating Procedures • Identify process improvement opportunities in end-to-end Data Management • Participate in small group activities, kaizen events, and Lean Six Sigma projects when necessary • Work a rotational night shift to support study and client needs across time zones • Collaborate with clients and internal teams to develop protocol-specific monitoring report specifications • Generate study-specific tools for flagging discrepancies between client IVR/EDC and TrialManager outputs • Conduct protocol reviews and identify protocol-specific device design and eligibility criteria • Define protocol-specific reports as necessary • Collaborate with the validation team to define detailed test cases for clinically significant reports

🎯 Requirements

• BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience • Technical aptitude and ability to complete high-quality technical documentation • Ability to understand and work with HTML and different types of clinical databases • Extreme attention to detail and organization • Ability to quickly learn and apply new skills, procedures, and approaches • Ability to meet very short deadlines and multitask in an extremely fast-paced work environment with little direct supervision • Ability to work independently and in a team-oriented environment • Proactive and positive approach to tasks and projects • Proficient in Access, Excel, and other office software technologies and applications • Ability to handle multiple competing priorities with minimal direct supervision • Strong verbal and written communication skills • Willingness and ability to work a night shift on a rotational basis • Familiarity with 21 CFR Part 11 or experience in a regulated environment • 3+ years of professional experience in the clinical trials data management field • Familiarity with data management best practices (GCP, GDPR, MHRA) • Familiarity with EDC systems

🏖️ Benefits

• Opportunity to work with cutting-edge AI technologies • Meaningful work and global impact • Innovation in clinical research and digital health

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