Planet Pharma
Remote Sr. Study Specialist, Global Study Operations
Planet Pharma, San Rafael, California, United States, 94911
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 Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Senior Student jobs in
San Rafael, CA . Fall 2025 SOFG Home Marketing Internship
Wellbeing Case Management Specialist (Student Services Professional IV) - Division of Student Life
San Francisco, CA $75,840.00-$83,880.00 1 day ago Machine Learning Intern/Co-op (Fall 2025)
San Francisco, CA $27.60-$38.40 2 weeks ago Intern — frontend / backend / full-stack
Sr. Study Specialist, Global Study Operations
Assistant Dean, Admissions and Financial Aid (Job ID #78364)
Student Brand Ambassador - University of California (UC) - Berkeley
San Francisco, CA $60,000.00-$120,000.00 1 month ago Vice President of Enrollment Management – San Francisco Bay University
San Francisco, CA $250,000.00-$265,000.00 3 weeks ago South San Francisco, CA $22.00-$24.00 1 day ago Assistant Dean, Admissions and Financial Aid (0303U), Berkeley Law - #78364
Sr. Study Specialist, Global Study Operations
School Assistant (Weekday Evenings) or Saturdays (12-5 pm)
Sr. Study Specialist, Global Study Operations
San Francisco, CA $24.00-$27.00 9 months ago Program Manager of Enrollment and Special Projects
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
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 Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Senior Student jobs in
San Rafael, CA . Fall 2025 SOFG Home Marketing Internship
Wellbeing Case Management Specialist (Student Services Professional IV) - Division of Student Life
San Francisco, CA $75,840.00-$83,880.00 1 day ago Machine Learning Intern/Co-op (Fall 2025)
San Francisco, CA $27.60-$38.40 2 weeks ago Intern — frontend / backend / full-stack
Sr. Study Specialist, Global Study Operations
Assistant Dean, Admissions and Financial Aid (Job ID #78364)
Student Brand Ambassador - University of California (UC) - Berkeley
San Francisco, CA $60,000.00-$120,000.00 1 month ago Vice President of Enrollment Management – San Francisco Bay University
San Francisco, CA $250,000.00-$265,000.00 3 weeks ago South San Francisco, CA $22.00-$24.00 1 day ago Assistant Dean, Admissions and Financial Aid (0303U), Berkeley Law - #78364
Sr. Study Specialist, Global Study Operations
School Assistant (Weekday Evenings) or Saturdays (12-5 pm)
Sr. Study Specialist, Global Study Operations
San Francisco, CA $24.00-$27.00 9 months ago Program Manager of Enrollment and Special Projects
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr