Manager, Clinical Data Management
Sucampo Pharmaceuticals, Inc. (SPI) is currently searching for a Manger, Clinical Data Management for the U.S. office located in Rockville, Maryland. SPI is a global biopharmaceutical company focused on innovative research and development of proprietary drugs to treat gastrointestinal, ophthalmic and oncology-based inflammatory disorders. Sucampo has a marketed product - AMITIZA® - and a pipeline including lifecycle management and clinical development programs. Sucampo is headquartered in Rockville, Maryland, and has operations in Japan, Switzerland and the United Kingdom.
The Manager within Clinical Data Management will manage internal and/or outsourced data management activities in support of multiple clinical research projects.
• As Lead Data Manager, work with cross-functional study team, third-party CROs and other data management staff on the:
• development of Data Management Plan (DMP)
• development of CRFs annotation and completion guidelines (CCG)
• design and test of databases
• development of edit-check specifications
• performance or management of query generation and resolution
• performance or management of AE/medication coding and SAE reconciliation
• Design data management metrics and effectively utilize metrics reports within EDC systems to ensure effective and efficient clinical data management contribution to the clinical study team against defined project timelines and priorities.
• Work with SAS programmers and/or CRO on regular/ad hoc listing/patient profile generation/review to ensure quality clinical data management deliverables.
• Work with line management and clinical team on the development of optimal resourcing model, processes and work flows for database setup, data capturing and cleaning, internal and external validation, and database lock and archiving, etc; work with clinical team and line management on selection and oversight of vendors for Data Management, EDC, IVRS, and ePRO as appropriate.
• Develop or contribute to the development of data management SOPs, development and accumulation of data management standards, work modules, and re-usable tools, ensure compliance with ICH, GCP, and regulatory and internal requirements.
• Supervise, coach and develop clinical data management professionals (internal and/or outsourced) working within clinical study teams.
1. Bachelor’s degree in Health Sciences or Quantitative fields
2. Minimum of 7 years hands-on experience in clinical trial data management at a pharmaceutical company or CRO
3. 1 - 2 years vendor management experience
4. Experience in conducting trials using EDC, IVRS, and ePRO
5. Experience in managing CROs and using metrics to monitor internal/external quality and activities
6. Experience in training and presenting at Investigator Meetings
7. Ability to use SAS for data review and knowledge of SAS programming are pluses
8. Experience in management of consultants and direct reports is a plus
9. Strong initiatives in identifying issues and proposing solutions with ongoing studies, a good investigative and meticulous approach to all activities and tasks
10. Demonstrated ability to operate independently and to influence decision-making processes within a matrix team environment
11. Leadership ability, interpersonal and organizational skills, and excellent communication and facilitation skills are a must.
Sucampo Pharmaceuticals, Inc. offers a competitive salary and benefits package including 401(k) with a generous company match as well as company-paid parking or metro expenses. If this position meets your qualifications and interest, please click "Apply Now" to apply.
Sucampo Pharmaceuticals, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. Sucampo Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Sucampo participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United State