Sr. Study Specialist, Global Study Operations

Planet Pharma; San Rafael (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

Planet Pharma seeks a Remote Sr. Study Specialist to oversee clinical studies focused on rare diseases. This role requires leadership skills and experience in vendor management, offering competitive hourly pay based on expertise. Join a team dedicated to advancing health outcomes for patients with few treatment options.

Qualifications

• Experience in biotechnology or pharmaceutical environments.
• Ability to oversee external vendors and manage budgets.

Responsibilities

• Contribute to site feasibility assessment and selection.
• Oversee IRB/EC submission and essential documents.
• Develop training materials for sites and investigators.

Skills

Agility

Communication

Collaboration

Education

BA/BS in nursing, life or health sciences

Job description

Remote Sr. Study Specialist, Global Study Operations

Join to apply for the Remote Sr. Study Specialist, Global Study Operations role at Planet Pharma

Remote Sr. Study Specialist, Global Study Operations

Join to apply for the Remote Sr. Study Specialist, Global Study Operations role at Planet Pharma

Job Description

Pay 50-60/h depending on experience

This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. The company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative company therapeutics, advancing the standard of care, and providing personalized support and services globally.

The Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Role Summary

Core Competencies

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:

• Agility and Proactivity
• Leadership
• Communication and Collaboration
  
  

Technical Competencies

• Study Management and Execution
• Compliance and Quality
• Drug Development and Study Design
• Product and Therapeutic Area Knowledge
  
  

Responsibilities Include But Are Not Limited To

• Develop study specific documentation, as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection.
• Oversight of CRO for IRB/EC related submission/approval activities
• Oversight of essential documents for study life-cycle management
• Develop/Oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• Process documents for signature in DocuSign
• Oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
• Oversee and manage essential documents in the Trial Master File (TMF)
• Contribute to Global Study Operations risks identification and mitigations.
• Provide support and administrative assistance with internal and external meetings
  
  

Requirements

• BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
• Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Education and Training

• Industries

  Staffing and Recruiting

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