Associate Manager, Clinical Operations & Development, Study Start Up

Company: Sage Therapeutics
Location: Cambridge
Posted on: November 18, 2022

Job Description:

General Scope and SummarySage Therapeutics is searching for a resourceful, confident professional with on-site monitoring experience for an important role as Associate Manager, Study Start Up on several fast-moving studies for one of our lead programs in the CNS space. This individual will own the collection, distribution, receipt, review, and registry of essential documents required for release of Investigational Product to participating investigator sites and any updates required as a result of document expirations and related protocol amendments.Roles and Responsibilities

• Efficiently manage and successfully execute aspects of global start up.
• Plan and track against the investigator list creation investigator assessment for eligibility/usability and selection to ensure that Site Essential Package distribution occurs in a time sensitive manner.
• Plan and track against Site Initiation and Site Activation timelines to drive against key study timelines.
• Perform quality checks on submission documents and site essential documents.
• Prepare and distribute informed consent forms for review and approval.
• Review pertinent regulations to develop proactive solutions to start up issues and challenges.
• Assist with establishing, developing, and delivering the Global Study Startup Project Plan.
• Partner with CROs, Clinical Operations teams, and cross-functional partners to improve overall study start up metrics and implement processes.
• Agree to deliverables on a site-level basis with the CRO and monitor adherence to these. Promptly recognize and improve potential delays and escalate non-performance.
• Partner with CRO to identify mitigation strategies and support strategies for sites that are not performing to expectation.
• Assist with resolution of site-specific activation issues.
• Participate as a member of the Site Activation team.
• Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed.
• Review Monitoring Visit Reports from the CRO.
• Perform monitor visits (Pre-Study Visit, Site Initiation Visit, Interim Monitor Visit, and/or Close Out Visit) as needed.
• Support vendor and site training efforts.
• Provide overall tactical support for the study.Experience, Education and Specialized Knowledge and SkillsMust thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, and good conflict management and negotiation skills. Must have the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.Basic Qualifications
  • BS/BA degree, or equivalent.
  • 4+ years of pharmaceutical or biotechnology industry experience, or equivalent; 1+ years of experience performing on-site monitoring conducting SIVs, IMVs, and COVs for IND regulated clinical research studies.Preferred Qualifications
    • Experience in CNS/neurology.
    • Thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
    • Experience executing tasks related to study start up and site activation.
    • Demonstrated effectiveness in resolving site management issues of varying complexity.
    • Co-monitoring experience required.
    • This role will require some travel, ranging from 10% - 25%.
    • Established ability to prioritize and manage multiple tasks simultaneously; demonstrated ability to identify and resolve issues and effectively manage timelines.
    • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
    • Proficient in MS Excel, Word, and PowerPoint. Knowledge of MS Project preferred.
    • Proactive and positive management approach.
    • Maximum flexibility to adapt to changing program needs in real time.
    • Strong leadership skills.
    • Strong team player that has a customer service approach and is solution-oriented.
    • Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
    • Excitement about the vision and mission of Sage.Employment Type:EmployeeNumber of Openings:1Job ID:R001417#Biotechnology #Careers #ThisIsSageAll Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.EEO is the Law (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEO is the Law - SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.#LI-RemoteProtected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy

Keywords: Sage Therapeutics, Cambridge , Associate Manager, Clinical Operations & Development, Study Start Up, Healthcare , Cambridge, Massachusetts