Medable’s mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.
Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.
Job Description
- Provide methodological and technical support for eCOA efforts by sales, in contract negotiations and implementation of all customer contracts
- Oversee performance management at the enterprise and per study level for eCOAs to ensure consistency and quality execution to contractual standards
- Work with Legal and Contracting teams to define terms for any eCOA partnerships and assist with management and delivery
- Lead effective Governance and relationship oversight with each partner for eCOA, engaging with key members of the Medable leadership team and other SMEs as needed
- Work cross-functionally with teams to ensure effective and timely assessment and management of eCOA products and initiatives
- Support Medable Development team with the assessment and evaluation of Medable’s eCOA products for usability and regulatory compliance
- Provide guidance and input into effective eCOA product usability and engagement at strategic and study levels, supporting the CS and Project Management functions as needed to ensure high-quality client delivery
- Provide operational oversight and leadership to ensure effective delivery of the proposed eCOA strategies to clients, with focus on quality, time, and cost as well as ICH GCP compliance and other eCOA specific regulatory requirements and expectations
- Define common qualitative and quantitative study metrics for eCOAs
- Oversee all aspects of eCOA operations and regulatory compliance for Medable’s internal and external clinical programs
- Work with management leadership team member to provide deep eCOA expertise to enhance Medable eCOA product design and implementation efforts for customers
- Establish and manage relationship with KOLs and SMEs for eCOA
- Other duties as assigned
Qualifications
Experience
- 12+ years of experience in clinical trials (sponsor and site)
- Budget forecasting and development experience and skillset
- A strong background in clinical trial science and clinical operations – strategy and delivery
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Experienced at cross-functional management of multiple projects and overall project timelines
- Experienced in developing teams and programs in a fast-paced environment with strong leadership and staff development
Additional Information
Skills
- Outstanding communication skills, both verbal and written
- Ability to work independently and prioritize duties
- Significant and deep knowledge of eCOA regulatory requirements and guidance, including maintenance of updated knowledge in this advancing field
- Strong leadership and influencing skills
- Strong writing, analytical and strategic skills
- Highly effective team player with exceptional interpersonal skills
Education, Certifications, Licenses
- PhD degree and research experience in eCOA implementation for DCTs or equivalent experience
Travel Requirements
- As Required
Medable, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All strongly held beliefs, religious, medical, and other legally recognized exemptions regarding vaccination status will be considered.