Study Operations Manager II - FSP

extra holidays - extra parental leave - fully flexible
Work set-up: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Bachelor's degree in Science or Arts with at least 7 years of clinical trial experience., Master's degree in Science or Business Administration with at least 6 years of relevant experience., Scientific or technical degree is preferred., Strong leadership and strategic planning skills in clinical study operations..

Key responsibilities:

  • Lead global study activities from startup to closeout.
  • Manage local study teams and oversee CRO and country-level activities.
  • Coordinate with regulatory and site partners on submission strategies.
  • Ensure timely study delivery through planning, vendor management, and issue resolution.

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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Study Operations Manager II (SOM II) has responsibilities for global study activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

  • Serves as leader of the local study team on one or more studies
  • Provides back up to or assumes the responsibilities of the GSM as needed
  • Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
  • May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable
  • Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
  • Provides country level input on startup and recruitment milestones during planning
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
  • Accountable for resolution of site activation escalations to study teams including offering options for mitigation
  • Fully responsible and accountable for, as designated by the GSM:
    • Implementation of startup and site activation plans
    • Development of recruitment strategy
    • Development of study level plans
    • Communication with the team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans
    • Vendor management and oversight including follow up and coordination of vendor deliverables
    • Assurance of the follow up and coordination of site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.

Requirements:

  • Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required
  • Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
  • A scientific or technical degree is preferred

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Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Strategic Planning
  • Leadership
  • Timelines
  • Empathy
  • Problem Solving

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