Early Development Senior Clinical Data Manager

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end-to-end data management activities pertaining to clinical trials, including but not limited to data management tool and system development validation and maintenance, data collection, data integrity review and reconciliation, query management and database lock preparation in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines. In Early Stage Development (ESD), the SCDM may have sole responsibility for these activities. In Late Stage Development (LSD), the SCDM's execution of these activities may be overseen by a Lead Clinical Data Manager (LCDM) or other manager.

• All responsibilities of a Clinical Data Manager (CDM)
• May be responsible for in-life and database lock tasks and activities.
• Assume data management responsibilities for larger, more complex, or higher priority protocols.
• Triage, research, discuss and resolve the reports outputs provided by Clinical & Statistical stakeholders at a protocol level during in-live and database lock stages. Execute special reports in different systems and coordinate resolution of the outputs.
• Responsible for the preparation, creation, and review of data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-Life Reports, Encoding and Data Management Plans (DMPs)
• Coordinate User Acceptance Testing (UAT) of the Clinical Database
• Responsible for the communication with Clinical team regarding site level issues on a protocol
• Coordinate communications, global status tracking, and issue resolution at study level.
• Interact and communicate with customers and stakeholders both internal and external to GDMS, as well as Merck, when needed.
• Responsible for study level status assessment, reporting and communication with LCDM (LSD), or with the assigned trial manager (ESD). Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to responsible parties.
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS)
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to Clinical stakeholders.
• Provide protocol specific training of SDE Process to CDM
• Coordinate and mentor CDMs and other SCDMs who work in same protocol to maintain compliance with SOPs, data management plans and data review plans.
• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring, and/or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials, as needed
• May contribute to special activities such as supporting Process Owner (PO) Models in the local DMC and/or in the Global PO networks
• Participate in cross-functional technical or process improvement projects

Minimum FTE Years of Experience

• At least 1 year of experience in Clinical Data management in pharmaceutical or health care clinical research environment preferred

• Self-motivated, excellent in work planning and time management
• Fluent oral and written English skills
• Good basic awareness of the clinical development process and clinical practice, and a grasp of medical terminology
• Good sense and awareness of regulations and policies
• Able to work under pressure and in a changing environment with flexibility
• Good communication skills with the ability to communicate in both technical and business matters
• Proven leadership skills, ability to speak up and contribute to decision making

Educational Requirements
BA or BS degree, life science, computer science or health care related
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.