We are dedicated to discovering, developing and commercializing therapies that transform patient lives and advance patient care by changing treatment paradigms in thrombosis and other hematologic diseases.
The company's two FDA approved medicines are Bevyxxa (betrixaban), the first and only oral, once-daily Factor Xa inhibitor, and Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote for the Factor Xa inhibitors rivaroxaban and apixaban. The company also is advancing cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers. These compounds come from our own internal research efforts and represent important advances to address significant unmet needs.
We are employing novel strategies that may increase the likelihood of clinical, regulatory and commercial success of our potentially lifesaving therapies.
The Senior Manager / Manager Clinical Data Management will support the Data Management group from study start-up through database lock and clinical study report. The successful candidate will deliver high quality data, on time and on budget. In this role, the candidate will be expected to lead and provide oversight for the execution of data management activities for more than one compound in a therapeutic area. This role will report to the Associate Director, Clinical Data Management.
Interacts with project leaders and other internal and external stakeholders to ensure adequate support of clinical projects and systems
Contributes to departmental development projects to improve quality, effectiveness and efficiency, including standards development
Collaborates with cross-functional department leads in the design and implementation of procedures, systems and standards
Contributes to the strategy of CDM
Manages studies and/or individuals, vendors, as applicable
Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data
Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards; including conducting and managing internal data quality reviews
Partners with clinical study team to create and validate database design, edit check specifications, data transfer specifications, and clinical listings and reports
Contribute in the development, revision and review of CDM SOPs, guidelines and Work Instructions
Maintains an ongoing focus on industry trends regarding opportunities and challenges; reports on issues identified in order to improve and develop department strategy with third parties regarding service levels - including CROs and other vendors
Bachelors or graduate level degree in Life Sciences, or similar
5+ years working experience in Data Management in pharmaceutical or CRO setting
Strong experience with EDC (Rave preferred), full development life cycle
Well-rounded technical skills: EDC, SAS, and CDISC
Working experience handling lab/image data
Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance
Practical knowledge of ICH, FDA, and GCP regulations and guidelines
Accuracy and attention to detail working with clinical data
Good planning, project management and organizational skills
Good people management skills
Excellent written and oral communication skills