Clinical Data Manager

Clinical Data Manager

• Prefers someone with experience in a few different therapeutic areas (peds would be a plus, but not required)
• Experience leading or implementing process improvement projects
• Minimum of 8 years of Clinical Data Management experience in a pharmaceutical or CRO setting; 10 years preferred.
• REMOTE: EST preferred. Some travel (less than 20%) could be required
• Will not have any direct reports
• Tools – Rave and Medrio
• Estimated W2 Hourly Pay: $75 - 85 - Must be able to work for Milestone directly on a W2 basis.
• Duration – 12 months

Clinical Data Manager

Manager, Data Management (Clinical)

POSTION SUMMARY

As part of the Biometrics department Senior Clinical Data Manager will work collaboratively in a fast-paced, cross-functional team environment. This individual will play a key role in ensuring accurate, high quality clinical trial data. Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals in accordance with Standard Operating Procedures (SOPs) and regulatory directives.

Provides oversight and leading activities for data management activities and ensures data management activities and deliverables are completed in line with business requirements and company objectives. Oversees performance and deliverables of data management service providers on assigned studies and programs as well as manages all aspects of the clinical trial data management process from study start up to post database lock for Electronic Data Capture (EDC) and paper CRF trials.

PRIMARY RESPONSIBILITIES

• Oversees program of DM service providers and external vendors on assigned studies and programs, ensuring milestones and quality deliverables are achieved on-time and in accordance with department and regulatory requirements
• Reviews and approves DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, User Acceptance Testing (UAT) documentation, Communication Plans, etc.
• Facilitates an internal cross-functional oversight plan to ensure data quality and demonstrate oversight, performs oversight of DM tasks as activities as needed.
• Attends and represents DM effectively on all assigned studies and programs at relevant meetings.
• Provides feedback on draft protocols, risk assessments, and functional area plans and outputs as appropriate (e.g. Medical Monitoring Plan, Statistical Analysis Plan (SAP), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.).
• Develops positive partnerships with internal and external stakeholders; engaging, collaborating, and communicating effectively.
• Collaborate with peers in the development and maintenance of Standard Operating Procedures (SOPs) and departmental processes as needed.
• Acquires and enhances knowledge related to drug development, clinical trials methodology, and DM best practices, and applies the information to make recommendations for improvement to processes and business performance.

QUALIFICATIONS

• Bachelor’s Degree in science, or related field required.
• Requires a minimum of 8 years of Clinical Data Management experience in a pharmaceutical or CRO setting; 10 years preferred.
• Bachelor’s Degree or higher, or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with less years depending on experience and education.
• Significant experience in managing outsourced data management activities.
• Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, and GCP.
• Current and extensive knowledge of industry DM best practices and processes.
• Strong experience with various clinical database management systems including EDC, eCOA, and ePRO.
• Strong and effective oral and written communication, project management, and interpersonal skills.
• Proven success working in a virtual, global and multi-cultural environment.
• Proven success in identifying creative solutions to complex study-related or technical issues.
• Knowledge of SAS, EDC programming, systems integration experience, understanding of CDASH and CDISC standards and, proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook are preferred.