Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking a Platform Design Manager eager to make an impact within a mission-driven organization.
The Platform Design Manager is responsible for working with our clients to define the Science 37 platform specification design for the study, including all data capture requirements. This position will define Science 37 standards, platform requirement, product changes and work with our sales team on understanding our client’s needs and expectations.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
- Define and Specify Science 37 Platform design requirements for assigned studies in conjunction with the Internal study team and the sponsor to meet protocol requirements.
- Subject Matter Expert for Science 37 on system capabilities for data capture and configuration
- 3. Assist in the implementation of standard templates and libraries to maximize efficiency and speed of delivery
- Interact with sponsors, project managers, platform build team and all levels of internal staff in highly cross-functional project teams, acting as the lead in designing and documenting data collection requirements for clinical studies
- Create, review, and maintain project timelines and monitor progress of platform design activities
- Participate in the review of SOPs, work instructions, and associated documents for platform design, including recommending revisions and updates to SOPs
Manage key partnerships and build effective working relationships with clients, sponsors, and vendors
Accountable for maintaining quality metrics, KPIs and measure study's performance against expected benchmarks
QUALIFICATIONS & SKILLS
The following qualifications are preferred and/or equivalent applicable experience:
- Bachelor’s degree preferred or equivalent experience in the health science field 2. 3+ years of experience in clinical research or life science industry, including at least 1 year in design of CRF/ePRO or other clinical trials database capture software.
- Extensive knowledge of the clinical research development process
- Relevant working knowledge of CDISC and SDTM standards
- Experience in a fast-moving, growth-minded company, and are comfortable with needing to be flexible and adaptable as requirements change.
- Understanding of drug development process and regulatory guidelines.
- 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.
- Experience in building and guiding organizational teams, leveraging each team member’s unique background and perspective to achieve team goals while providing clear direction and accountabilities
- Proactive problem-solving abilities and follow through
- Successful situational responsive decision-making
- Strong communication and presentation skills – both written and verbal
- Ability to articulate ideas to both technical and non-technical audiences
- Ability to establish and maintain positive sponsor, project team member, vendor and internal Science37 relationships
- Have excellent time management skills, action-oriented, goal-oriented, and innovative 11. Demonstrates high level of attention to detail, outstanding organizational activities and good blend of analytical skills, strategic thinking, planning and implementation
- Working knowledge of Microsoft Office suite, Google applications, and electronic clinical technologies.
- Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
- Ability to communicate in English (both verbal and written)
The incumbent is required to work independently and under guidance of the Associate Director, Platform Design.
Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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!
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