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Associate Manager, Clinical Ops & Development

Employer
Sage Therapeutics
Location
Working from Home
Start date
Jan 26, 2022

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time

Job Details

General Scope and Summary

Sage Therapeutics is searching for a resourceful, confident professional with onsite monitoring experience for an important role as an Associate Manager on several fast-moving studies for one of our lead programs in the CNS space. The Associate Manager will provide support to study management tasks in collaboration with the Study Manager and/or Senior Managers, with an emphasis on leading monitoring oversight activities for our clinical CROs.

Roles and Responsibilities

  • Lead monitoring oversight and study management tasks in collaboration with Study Manager and/or Senior Study Manager.

  • Lead training of CRO CRAs and creating the CRA training material.

  • Accountable for CRO CRA oversight.

  • Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan as needed.

  • Review Monitoring Visit Reports from the CRO.

  • Monitor studies (PSV, SIV, IMV, COV) as needed.

  • Ensure adequate monitoring resources, CRA selection, and training.

  • Escalate, interpret, and analyze monitoring trends or findings to the Study Manager.

  • Participate in data cleaning and data trend review as necessary.

  • Drive and lead adherence to the Sponsor Oversight and the Monitoring Plan.

  • Assist in start-up activities of clinical research studies including investigator meetings, enrollment planning, and investigator selection.

  • Collaborate closely with Sage study management, CRO study managers, and CRO monitoring staff; review site/patient activity tracking, prepare study updates, and proactively identify and solve study-related issues.

  • Regularly communicate with Investigators to identify and resolve complex clinical study conduct issues and ensure site compliance with Good Clinical Practice and federal and applicable local regulatory requirements.

  • Guide investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability.

  • Review and provide input to study plans and guidelines, including study monitoring plans.

  • Assist in the development of study documents, such as informed consent forms, study logs, and study manuals.

  • Support vendor and site training efforts.

  • Provide overall tactical support for the study.

  • Lead or assist with TMF processes: set-up, training, QC, and management; collaborate with CRO counterpart.

Experience, Education and Specialized Knowledge and Skills

Must 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, good conflict management and negotiation skills, and 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 and 4+ years experience in Clinical Development and Operations.

  • At least 1+ years of experience performing onsite monitoring conducting SIVs, IMVs, and COVs for IND-regulated clinical research studies.

  • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.

Preferred Qualifications

  • Demonstrated effectiveness in resolving site management issues of varying complexity.

  • Co-monitoring experience required.

  • This role will require some travel, ranging from 10% - 50% during peak study activity.

  • Strong communication and interpersonal/team skills.

  • Proficient in MS Excel, Word, and PowerPoint. Knowledge of MS project preferred.

  • Established ability to prioritize and manage multiple tasks simultaneously, 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.

  • Embrace our Core Values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

  • Excitement about the vision and mission of Sage.    

Employment Type:Employee

Number of Openings:1

Job ID:R001099

#Biotechnology #Careers #ThisIsSage

All 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.

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

EEO is the Law - Poster Supplement

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.

Company

Welcome To The Workplace With A Difference

Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.

At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.

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Stock Symbol:

SAGE

Company info
Website
Phone
617-299-8380
Location
215 First Street
Cambridge
MA
02142
United States

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