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Clinical Research Manager (Contract - Multiple Locations)

Company: Evidation Health
Location: San Mateo
Posted on: April 9, 2021

Job Description:

Clinical Research Manager (Contract - Multiple Locations) *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 - Special Projects you will be responsible for the operational management and execution of clinical trials. The Clinical Research Manager - Special Projects 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 digital health based 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. This is an in itial 12 month remote contract position. 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
  • Be accountable for overall operational execution of multi-site decentralized digital clinical studies including but not limited to coordination with site staff, vendors and study sponsor
  • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • 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 study timelines with Project Manager to define program targets, meet critical milestones; escalate issues that may jeopardize timelines and deliverables
  • Provide oversight and direction to study team members, including vendors, for study all deliverables
    • Manage and coordinate study staff (i.e CRCs, CRAs, etc.)
    • Track and monitor study staff training and metrics based performance
    • Create and deliver updates to internal and external stakeholders including the Sponsor
    • Manage clinical study monitoring activities to ensure data integrity through oversight of routine data reviews and consistency checks and quality metrics--
    • Develop, maintain and provide oversight on clinical study management plans, study documents, study materials, process guides, monitoring tools and templates
    • 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
    • Moderate travel may be required Minimum Qualifications:
      • 5+ years of experience in clinical study management
      • Undergraduate university degree required
      • Thorough knowledge of the entire clinical research process including experience in site management, clinical operations and clinical project management
        • Knowledge of ICH GCP guidelines and FDA regulation for clinical research
        • Experience working on behalf of sponsor and/or CRO preferred
        • Experience in digital health and/or decentralized trials strongly preferred
        • Prior experience with CRA/CRC management and demonstrated experience leading teams
        • Strong project management, organizational, and interpersonal communication skills 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
          • Challenge each other and state your good intent
          • Go fast while maintaining quality and integrity
          • Work to win together Are you authorized to work lawfully in the United States? --*
            -- Will you now or in the future require visa sponsorship? --*
            -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Evidation are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
            • Autism
            • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
            • Blind or low vision
            • Cancer
            • Cardiovascular or heart disease
            • Celiac disease
            • Cerebral palsy
            • Deaf or hard of hearing
            • Depression or anxiety
            • Diabetes
            • Epilepsy
            • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
            • Intellectual disability
            • Missing limbs or partially missing limbs
            • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
            • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Evidation Health, San Mateo , Clinical Research Manager (Contract - Multiple Locations), Healthcare , San Mateo, California

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