Associate Manager, Clinical Operations & Development, Study Start Up
Company: Sage Therapeutics
Posted on: November 18, 2022
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
- Efficiently manage and successfully execute aspects of global
- 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
- Plan and track against Site Initiation and Site Activation
timelines to drive against key study timelines.
- Perform quality checks on submission documents and site
- Prepare and distribute informed consent forms for review and
- 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
- Demonstrated effectiveness in resolving site management issues
of varying complexity.
- Co-monitoring experience required.
- This role will require some travel, ranging from 10% -
- 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
- Proactive and positive management approach.
- Maximum flexibility to adapt to changing program needs in real
- Strong leadership skills.
- Strong team player that has a customer service approach and is
- 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
is the Law - SupplementPay Transparency Nondiscrimination
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
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