Senior Clinical Data Manager

Responsibilities

• Oversight of CRO data management counterparts for assigned clinical trials
• Ensuring data management objectives are met in accordance with current SOPs, WPDs and timelines and budget
• Initiation of CRF development for new clinical trials and protocol amendments
• Collaboration with internal team and responsible vendor on CRF development, database design and edit specifications
• Ensuring established clinical data standards are followed
• Reviewing CRO Data Management Plans, Data Review Plans and other applicable data management documents for completeness and accuracy
• Creation and tracking of internal Data Review Plans for review/approval by study team members
• Coordination of the internal data review process
• Reviewing and creating Data Transfer Plans for external data vendors
• Performing external data reconciliations as applicable
• Reviewing and creating protocols, Statistical Analysis Plans and statistical outputs
• Aiding in the creation/review of clinical data standards, DM WPDs and Instruction Documents

Qualifications

• Completed BA/BS degree in a scientific or health care field preferred
• 5+ years prior experience in clinical data management
• Proficient in Medidata Rave; strong understanding of system configuration requirements and specifications
• Experience with clinical data standards; knowledge of CDISC standards preferred
• PREFERRED: Experience with immunology, dermatology and allergy
• In-depth knowledge of data management, including interpretation and implementation of FDA regulations
• Excellent oral and written communication skills
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
• Strong organizational, multitasking, and priority management skills
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook

Benefits

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.