Aerotek Clinical Data Manager/Senior Clinical Data Manager in MALVERN, Pennsylvania
• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.
• Responsible for coordinating periodic clinical data reviews for quality and surveillance to ensure data quality and data logic
• Coordinates all activities in preparation for database lock, including Data Review Meeting.
• Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data.
• Facilitate coordination of reconciliation and reporting activities between pharmacovigilance product databases, study safety and clinical databases
• Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
• Represent data management in preparation and coordination of final data transfers, archiving, and coordination to support regulatory submissions
Bachelor’s degree in a related field (e.g. life sciences or pharmacy), or allied health degree with extensive professional experience in the field
• Minimum 2 years experience in data management assigned projects
• Experience with InForm, RAVE or other EDC software
• Expertise in good data management procedures, industry best practices and data cleaning tools
• Experience supporting Oncology programs, with experience supporting Phase 2 and 3 studies
• Proficient computer skills including MS Office
• Good knowledge of GCPs, ICH and FDA regulatory requirements governing human clinical trials
• Demonstrated attention to detail and outstanding organization skills
• Ability to prioritize and handle multiple tasks simultaneously
• Self-motivated with a commitment to high quality, on-time deliverables
• Excellent communication and collaboration skills with team-oriented approach
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.