Sumitomo Pharma America, Inc. · 17 hours ago
Senior Manager, Clinical Data Management
United States
Full-time
Remote
Senior Level
$151K/yr - $189K/yr
6+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various therapeutic areas. They are seeking a Senior Manager for Clinical Data Management to oversee project and clinical trial data management, ensuring high standards of data quality and compliance with operational procedures.
Pharmaceuticals
Responsibilities
Work closely with outsources clinical data management (CDM) activities with various Contract Research Organizations (CROs)
Ensure study team expectations with regards to data quality are clearly communicated to, documented and delivered by the CRO
Provide comprehensive data management expertise to Data Management to provide efficient data management products that meet customer needs
Serve as the Lead Data Manager on studies
With minimal guidance, manage delivery of projects through full data management process life cycle
Understand and comply with core standard operating procedures (SOPs) and working instructions
Review and approve various CDM documents such as data management plan, CRF, validation plan and vendor specifications to ensure criteria are complete, comprehensive and appropriate
Communicate ideas for process improvement
Provide input in developing and implementing new technology
Provide project updates to management weekly and monthly
Develop and maintain good communication and working relationships with Project Team
Ensure proper archiving of study data and applicable documents
Requires ability to use a personal computer for extended periods of time
Qualification
Required
Minimum 8 – 12 (w/o Master's) or 6 – 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry
Thorough knowledge of the data management process
Thorough understanding of clinical trial methodology, GCP and medical terminology
Electronic Data Capture (EDC) experience, preferably Rave EDC
Ability to work independently, under pressure demonstrating initiative and flexibility
Excellent organizational, communication and data management skills (detail oriented)
Good interpersonal skills and ability to operate effectively in an international environment
Good technical and problem-solving skills
Ability to establish and maintain effective working relationships with peers, managers and clients
Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of SMPA are carried out with the best industry practices and the highest ethical standards
Must be able to exercise appropriate judgment, as necessary
Requires a high level of initiative and independence
Excellent written and oral communication skills required
Benefits
Opportunity for merit-based salary increases
Overtime
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Leaves provided in line with your work state
Up to 120 hours of vacation per year
11 paid holidays
Additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Access to our service recognition program
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
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