
Clinical Data Manager
2 days ago
Role Overview
The Clinical Data Manager is responsible for collaborating with the Clinical Data Management team and other internal stakeholders to deliver accurate, high-quality, and timely data management services for customers. This role provides expert guidance on data management activities, authors study-specific documents, ensures compliance with standards, and drives continuous improvement in processes and deliverables.
Key Accountabilities:
- Collaborate across functional groups to resolve technical issues impacting data quality and support technical initiatives within Data Management.
- Provide data management guidance to internal project team members and customers.
- Communicate effectively with internal stakeholders and customers on all aspects of study-specific data management activities.
- Author Data Management Plans (DMPs) and Data Transfer Specifications (DTS).
- Perform user acceptance testing (UAT) on reports and automated data checks used in data cleaning activities.
- Review, evaluate, and act on outputs from automated data checks.
- Facilitate risk assessments for mid-study changes.
- Verify data extracts against DTS requirements.
- Provide proactive data monitoring as per contractual obligations.
- Facilitate and verify data clarifications, corrections, and external data reconciliation.
- Contribute to process improvements that reduce timelines, increase quality, mitigate risks, and enhance overall team performance.
- Ensure effective communication within multidisciplinary project teams to meet deadlines and budgets.
- Assist in developing and enhancing Standard Operating Procedures (SOPs), Working Instructions, and Best Practices.
KNOWLEDGE, SKILLS & ATTRIBUTES
Essential:
- BA/BS degree in Medicine, Statistics, Computer Science, or a related field (or equivalent experience).
- Strong verbal and written communication skills.
- Ability to produce high-quality technical documentation.
- Excellent attention to detail and organizational skills.
- Quick learner with ability to adapt to new procedures, tools, and approaches.
- Proven ability to meet tight deadlines and manage multiple priorities in a fast-paced environment with minimal supervision.
- Effective collaborator with a strong ability to work both independently and as part of a team.
- Positive, proactive, and adaptable approach to tasks, projects, and process changes.
Desirable:
- 5+ years of professional experience in clinical trial data management.
- Experience in providing data management services within the clinical trials industry.
- Proficiency in MS Access, Excel, and related office software applications.
- Ability to manage multiple competing priorities under minimal supervision.
- Familiarity with 21 CFR Part 11 or experience in a regulated environment.
DECISION MAKING AND INFLUENCE
- Participate in data-related special projects and departmental initiatives.
- Mentor and support less experienced staff, ensuring adherence to project-specific and standardized data management processes.
- Represent Clinical Data Management during client meetings, audits, inspections, and bid defenses.
We know that everyone has different wants and needs, which is why along with a highly competitive base salary we support our people and their loved ones with a variety of perks and benefits. As part of our team some of the benefits you can expect to receive are:
- Medical Insurance, Group Accidental Coverage/Insurance, Group Term Life Insurance
- Company Paid Subscription to Calm – The #1 app for mental fitness.
- Employee Referral Program – Bring the Best to Signant Health and earn a reward.
- Wellness Program – Participate in challenges and earn points for rewards.
- Proof – Signant's Employee Recognition Program where you can accumulate points to redeem
- exciting merchandise, gift cards, tickets, and more.
- Burn Along – Digital fitness and wellness platform
Does this sound like something you'd like to explore? Then we'd love to hear from you
To apply, please submit your CV and a cover letter letting us know why you think you'd be perfect for this role. We will begin reviewing submissions during the application period and will fill the vacancy as soon as a suitable candidate is identified.
LI -SS1At Signant Health, accepting difference isn't enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.
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