Science 37, a GV funded life sciences start up, is looking for a Clinical Data Manager to lead and scale our engineering organization, of whom there are currently 25 team members. You will sit on the Senior Leadership Team. This is a unique opportunity to own, build and lead a team and ensure that we are continuously driving technical value without compromising quality, security and stability.

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients’ homes. By leveraging the latest innovations in mobile technology, cloud services, telemedicine, and mass-engagement channels like Facebook and Google, we are breaking down traditional geographic barriers to patient trial participation while shortening the time needed to bring new treatments to market.

As the Clinical Data Manager you will lead the clinical data management day to day effort for clinical form development, validation and data cleaning using Science 37’s proprietary electronic platform. This includes developing a standard form specifications, standard library of forms, form design, testing and validation in NORA, creating eCRF data entry guidelines, data management and data edit check plans and leading user acceptance testing. In addition, this position is responsible for performing data review, query generation and data cleaning activities through database lock.

DUTIES AND RESPONSIBILITIES

• Manage the Design specification, development, testing and validation of electronic case report forms, edit checks standards and dataset extraction.
• Develop and test form development in NORA, create and test edit checks in NORA and perform user acceptance testing within specified project timelines
• Assess database design requirements relevant to data capture, data extraction, processing and reporting.
• Accountable for audit readiness for data acquisition process and documentation.
•  Responsible for writing Data Management SOPs and any work instructions inclusive of the database design, data cleaning (electronic and manual query generation and data clarifications process), through database lock activities with strict adherence to Science 37 SOPs and Corporate Policies. 
• Review of Sponsor related SOPs to ensure Science 37 conformance with Sponsor requirements
• Lead data review and cleaning efforts, Tack CRFS, queries and status of data cleaning efforts through Database lock. Including developing and preparing tracking reports and tools.
• Review electronic discrepancies, issue manual and electronic queries and resolve queries.
• Perform manual and electronic review of updates in the database based upon documentation as outlined in the data management plan inclusive of Self Evident Corrections) and the manual data review process.
• Review data listings for any further DCFs. In addition, review data listings to ensure data quality.
• Maintain project specific data management documentation in accordance with regulations for the Trial Master File
• Assist in the overall Quality Control processes across all studies.
• Make recommendations to management concerning complex technical issues and provide solutions
• Provide input to department/Company process improvement activities.
• Collaborate with clinical program managers and clinical research coordinators. 

Qualifications  

• Bachelor of Science degree or equivalent experience in the health science field.
• 7+ years’ experience as Data Manager (or proven managerial experience) with at least 3 years experience creating forms, cleaning data and leading and performing User Acceptance testing in an electronic 21 CFR compliant electronic data capture system
• Has proven experience leading teams and creating CRF specifications, managing CRF timelines, designing and developing CRFs based upon protocol requirements
• Requires at least 3 years of experience in a CRO, pharmaceutical or biotechnology industry data management environment (transferable skills).

Skills/Competencies

• Experience with CDISC and SDTM (Study Data Tabulation Model) Standards in form design and electronic form build in a 21 CFR compliant data capture system.
• Expertise in project management - demonstrated ability to successfully manage people/projects. Proactive problem solving abilities and follow through.
• Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making. Be knowledgeable in regulatory requirements for electronic submissions.
• Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to create and review protocols, programs, and assess the success of a project.
• Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, project team member and internal Science37 relationships. Ability to conduct effective presentations.
• Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.
• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
• Other – Ability to communicate in English (both verbal and written)