eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
OVERVIEW
The Senior Clinical Data Manager (Sr. CDM) independently acts as a study lead and is responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects throughout the full data management lifecycle. The Sr. CDM is viewed as the CDM expert fostering cross-functional collaboration across clinical operations, biostatistics, and programming teams. Serves as the primary CDM Subject Matter Expert between eClinical personnel and Sponsor personnel.
The Sr. CDM will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. The Sr. CDM may delegate tasks/responsibilities to multiple team members in multiple projects. The Sr. CDM will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables.
KEY TASKS & RESPONSIBILITIES
- Primary representative for eClinical Solutions/Sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved Scope
- Senior technical resource providing Data Management services for project requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management, Vendor Reconciliation
- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities
- Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate® Data Central and analytics modules
- Function as senior DM consultant to sponsor providing guidance on data management best practices as applied to sponsor and protocol specific situation
- Perform data trending review via reporting and elluminate analytics to identify risks and develop mitigation and data cleaning strategies
- Monitor and interpret key performance indicators (KPIs), dashboards, and reports to provide actionable recommendations to client
- Delegate and prioritize tasks, provide project oversight and guidance to study data management team mentoring junior level staff and peers on all associated tasks within a study helping to grow individual capabilities
- Support business development by participating in proposal defenses
- Maintain project documentation related to assigned tasks
- Other duties as assigned
CANDIDATE’S PROFILE
Education & Experience
- 8-10 years of experience in Clinical Data Management
- Bachelor’s degree in health-related field or equivalent experience
Professional Skills
- Strong project management experience and project team leadership skills including work planning and work delegation
- Strong consulting and client relationship management skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent verbal and written communication skills
- Excellent team player
- Excellent knowledge of English
Technical Skills
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
- Proficient with EDC and Clinical Data Management Systems
- Experience with data reporting tools such as Qlik, JReview, Spotfire
- Experience with RBQM methodology preferred
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
Top Skills
eClinical Solutions Bengaluru, Karnataka, IND Office
eClinical Solutions Bangalore Office Office
Bengaluru, India
