Platform Design Manager
Science 37
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Posted:
August 29, 2023
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Remote
About the position
The Platform Design Manager at Science 37 is responsible for defining and specifying the platform design requirements for clinical studies, ensuring they meet protocol requirements. They will serve as a subject matter expert on system capabilities for data capture and configuration, and work closely with internal teams and clients to design and document data collection requirements. The Platform Design Manager will also manage key partnerships, maintain quality metrics, and measure study performance. The ideal candidate will have a bachelor's degree in a health science field, experience in clinical research or the life science industry, and knowledge of CDISC and SDTM standards.
Responsibilities
- Define and specify Science 37 platform design requirements for assigned studies
- 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 internal staff to design and document 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
- Manage key partnerships and build effective working relationships with clients, sponsors, and vendors
- Accountable for maintaining quality metrics, KPIs, and measuring study's performance against expected benchmarks
- Understand the drug development process and regulatory guidelines
- Knowledgeable about critical elements for success in clinical trials
- Ability to create and review protocols, programs, and assess project success
- Experience in building and guiding organizational teams
- Proactive problem-solving abilities and follow-through
- Successful situational responsive decision-making
- Strong communication and presentation skills
Requirements
- Bachelor's degree preferred or equivalent experience in the health science field
- 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
Benefits
- Fast-moving, growth-minded company
- Flexibility and adaptability as requirements change
- Understanding of drug development process and regulatory guidelines
- Knowledgeable about critical elements for success in clinical trials
- Ability to create and review protocols, programs, and assess project success
- Experience in building and guiding organizational teams
- Proactive problem-solving abilities and follow-through
- Successful situational responsive decision-making
- Strong communication and presentation skills
- Ability to articulate ideas to both technical and non-technical audiences
- Ability to establish and maintain positive relationships
- Excellent time management skills
- Working knowledge of Microsoft Office suite, Google applications, and electronic clinical technologies
- Ability to travel up to 20% for meetings and conferences
- Equal opportunity/affirmative action employer
- Values the well-being of employees
- Provides team members with everything they need to succeed