Associate Clinical Data Manager - Operations

About Signant Health
At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands-on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.

Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals.

If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting-edge AI technologies — you will find purpose and opportunity at Signant Health.

About the Role
The Associate Clinical Data Manager is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers, ensuring on-time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes.

Shift: This role requires working a night shift on a rotational basis.

KEY ACCOUNTABILITIES – Function


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, ensuring DM milestones are met.
Develop other study-specific documentation manuals, including but not limited to the Maintenance Guide (MG), as necessary.
Conduct study-specific trainings with internal Data Coordinators and Data Reviewers prior to release of the Data Management Plan initiatives.
Adhere to Signant Health Standard Operating Procedures for all data management responsibilities.
Identify areas of opportunity for improvement in the end-to-end Data Management process, driving out waste, increasing productivity, and delivering quality.
Support delivery of improvements in the Data Management process by participating in small group activities, kaizen events, and Lean Six Sigma projects when necessary.
Work a night shift on a rotational basis to support study and client needs across time zones.


Decision Making and Influence


Collaborate with clients and internal Delivery teams to develop and maintain protocol-specific monitoring report specifications.
Collaborate with clients and internal Data Coordinators and Data Reviewers to generate a study-specific tool for flagging discrepancies between the client IVR/EDC and TrialManager outputs.
Collaborate with clients and the internal Technical Client Services team to conduct protocol reviews and identify protocol-specific device design and eligibility criteria.
Collaborate with clients and the internal Technical Client Services team to define protocol-specific report(s) as necessary.
Collaborate with the internal validation team to define detailed test cases for clinically significant reports.


KNOWLEDGE, SKILLS & ATTRIBUTES

Essential:

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 as well as different types of clinical databases.
Demonstrates extreme attention to detail and organization in all aspects of work; previous project management experience is an advantage.
Ability to quickly learn and apply new skills, procedures, and approaches.
Demonstrated ability to meet very short deadlines and multi-task in an extremely fast-paced work environment with little direct supervision.
Proven ability to work both independently and in a team-oriented environment, providing back-up support to team members and establishing/maintaining effective working relationships with co-workers within and across functional areas.
Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling and process changes that are inherent in a fast-paced business.
Proficient in Access, Excel, and other office software technologies and applications.
Proven ability to handle multiple competing priorities in a fast-paced work environment with minimal direct supervision.
Strong verbal and written communication skills.
Willingness and ability to work a night shift on a rotational basis.


Desirable:

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.