This is a fully Remote and Work From Home (WFH) opportunity within the US
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry, one patient, at a time. To help us achieve our goal, we are seeking a razor-sharp Director, Platform Build Services eager to make an impact within a mission-driven organization.
The Director, Platform Build Services manages the platform build, testing, and implementation of the direct data capture on the Science 37 Platform.
The Director interacts with sponsors, platform design team, data managers, project managers and all levels of internal staff in highly cross-functional project teams, acting as the lead in building, testing, and implementing data collection for clinical studies.
Duties include but are not limited to:
- Lead, direct, manage, develop, coach, and evaluate the platform build services team in accordance with the Company's policies and plans
- Define and execute the standardization, build and testing of all clinical studies run at Science 37.
- Collaborate with other departments including Clinical Operations to provide early strategic input into protocol and design based on experience and limitations on how the studies are built.
- Direct all phases of the company’s Platform Build Services including Database build, CRF design, Internal testing/verification, and sponsor UAT.
- Develop and maintain SOPs related to Platform Build Services
- Work closely with the Platform design team and Data Management team to ensure smooth project transition and execution of projects
- Oversee project awards, progress, milestones, and delivery timelines to ensure proper resource allocation for successful project deliverables against goals and timelines
- Develop recruitment and retention strategies in collaboration with the HR department
- Work closely with Product Management on new or updated features to the Science 37 platform to support the platform build and eConsent processes to meet sponsor requirements and increase efficiency to the teams.
- Bachelor of Science degree or equivalent experience in the health science field
- 10+ years of experience in clinical research with 3+ years of management experience preferred
- 5+ years’ experience building EDC, eSource, eCOA or other custom data capture solutions
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH, GCP and CDISC
- Knowledge of 21 CFR compliance
- Experience creating forms, cleaning and delivering data in an electronic 21 CFR compliant electronic data capture system
- Knowledge of the clinical research development process
- Excellent interpersonal, communication (oral and written), analytical and organizational skills
- Excellent team management skills: ability to lead, train and mentor team members at all levels
- Experience in building and guiding organizational teams. Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities. Commitment to collaboration, within and across departments.
- Understands interpersonal and group dynamics and reacts in an effective and tactful manner and has a range of interpersonal skills and approaches with ability to select a best-fit approach.
- Ability to motivate, influence and guide team members and direct reports; gains commitments from others.
- Proven ability to manage multiple projects and complex timelines in a team environment.
- Strong influencing and negotiation skills
- Ability to mobilize a team to be both productive and proactive
- Ability to communicate in English (both verbal and written)
The incumbent is required to work independently and under the guidance of the Senior Director, Data Management and Clinical Systems.
The following positions report to the Director, Platform Build Services
- Senior Platform Build Specialists
- Platform Build Specialists
- eConsent Build Supervisor
- eConsent Build Coordinator
- Platform Testing Specialist
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!