*Considering candidates in San Mateo, Santa Barbara, or US based remote*

Evidation Health is seeking a motivated candidate who is passionate about defining value within digital health as a member of an agile, entrepreneurial team. As a Clinical Research Manager, you will function as the study team leader and play a key role in supporting the design, management, implementation and conduct of the execution of decentralized clinical studies. As a member of the team, you will collaborate with the product/engineering and project management teams to ensure clinical studies meet or exceed high quality standards.

RESPONSIBILITIES

• Be accountable for overall operational execution of multi-site digital clinical studies including but not limited to coordination with site staff and study sponsor
• Contribute and provide direction and operational leadership to ensure high-quality, on time, within budget, clinical studies by tracking the development of budget items, milestones and timelines, in addition to contributing to the scope and management of resources
• Coordinate clinical monitoring team and associated study monitoring activities to ensure data integrity through oversight of routine data reviews and consistency checks and quality metrics
• Manage, and develop a team of Specialists/Associates/Senior Associates, including task management and oversight, professional development and mentorship, and the fostering of a positive working environment that empowers team members to grow and contribute
• Develop, maintain and provide oversight on clinical study management plans, study documents, study materials, process guides, monitoring tools and templates
• Manage accountability and reconciliation process of study devices
• Identify and drive risk management and mitigation initiatives including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished and communicating risks internally and externally
• Support the implementation and management of an eTMF system
• Ensure clinical studies are in compliance with ICH GCP, internal SOPs and all other applicable regulations
• Moderate travel may be required

QUALIFICATIONS

Minimum Qualifications:

• Undergraduate degree
• 7+ years clinical research experience in site monitoring, clinical operations and clinical project management
  
  • Knowledge of ICH GCP guidelines and FDA regulation for clinical research
• 3+ years demonstrated experience leading teams and managing personnel
• Experience working with eTMF and EDC systems
• Strong project management, organizational, and interpersonal communication skills
• Efficient multi-tasker able to juggle multiple projects in various phases simultaneously
• Excellent attention to detail
• Works well with minimal direction
• Versatile team player with affinity for collaborative environment
• Proficient in: Google Docs and Sheets; Microsoft Word, Excel, and PowerPoint

Preferred Qualifications:

• Experience working on behalf of sponsor and/or CRO

ABOUT EVIDATION

Evidation measures health in everyday life and enables anyone to participate in groundbreaking research and health programs. Built upon a foundation of user privacy and control over permissioned health data, Evidation's Achievement platform is trusted by millions of individuals—generating data with unprecedented speed, scale, and rigor. We partner with leading healthcare companies to understand health and disease outside the clinic walls. Guided by our mission to enable and empower everyone to participate in better health outcomes, Evidation is working to bring people individualized, proactive, and accessible healthcare—faster.

OUR VALUES

• Put individuals first
• Challenge each other and state your good intent
• Go fast while maintaining quality and integrity
• Work to win together

OUR BENEFITS & PERKS

• Competitive salary + performance bonus + equity
• Medical, dental, and vision benefits with generous company contribution
• Company-provided life and disability insurance
• 401(k) with company contribution
• Wellness and wearable device reimbursements, mental health benefits, wellness programs
• Employee advisory committee focused around diversity, equity, inclusion, and belongingness
• Distributed teams and flexible work hours
• Take time when you need it: 13 paid company holidays + flexible time off
• Paid parental leave
• Mobile phone, home internet, and home office furniture reimbursements
• Apple laptop and your choice of monitor + noise cancelling headphones
• LinkedIn Learning and other professional growth opportunities

EVIDATION HEALTH VALUES DIVERSITY AND IS COMMITTED TO EQUAL OPPORTUNITY FOR ALL PERSONS WITHOUT REGARD TO RACE, COLOR, CREED, RELIGION, MARITAL STATUS, AGE, NATIONAL ORIGIN OR ANCESTRY, POLITICAL ACTIVITY OR AFFILIATION, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION INCLUDING GENETIC CHARACTERISTICS, MARITAL STATUS, SEXUAL ORIENTATION, GENDER IDENTITY, SEX OR GENDER.