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.
Bachelor’s degree in Health Sciences or Quantitative fields
Minimum of 7 years hands-on experience in clinical trial data management at a pharmaceutical company or CRO
1 - 2 years vendor management experience
Experience in conducting trials using EDC, IVRS, and ePRO
Experience in managing CROs and using metrics to monitor internal/external quality and activities
Experience in training and presenting at Investigator Meetings
Ability to use SAS for data review and knowledge of SAS programming are pluses
Experience in management of consultants and direct reports is a plus
Strong initiatives in identifying issues and proposing solutions with ongoing studies, a good investigative and meticulous approach to all activities and tasks
Demonstrated ability to operate independently and to influence decision-making processes within a matrix team environment
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 submit your resume to: www.sucampo.com/careers
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
Additional Salary Information: Commensurate with experience.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) is a global biopharmaceutical company that is built on the ongoing pursuit of scientific innovation to improve the lives of patients. Sucampo has one marketed product – AMITIZA® – and a pipeline including lifecycle management and clinical development programs. A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan..., Switzerland and the United Kingdom. For more information, please visit www.sucampo.com. The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.Follow us on Twitter (@Sucampo_Pharma).