Curebase logo

Clinical Project Manager

Curebase

Job description

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing. Curebase’s software technology and virtual staff enables recruitment and clinical data collection settings almost anywhere - from local clinics, to mobile care, telehealth, drive through sites, pharmacies and more.

Curebase is looking for a Clinical Project Manager (CPM) to join our expanding team. Join a group of hardworking clinical research professionals dedicated to leading innovations in our industry.

JOB TITLE: Clinical Project Manager

DEPARTMENT/GROUP: Clinical Operations

POSITION REPORTS TO: Director of Clinical Operations

SUMMARY OF POSITION:


Responsible for the execution of assigned human subjects research projects (e.g., clinical trials, observational studies) by organizing and guiding the activities of cross-functional teams to ensure compliance with the protocol, SOPs, and applicable regulatory requirements, as well as allocated budget, timeline, and scope.

ESSENTIAL DUTIES AND RESPONSIBILITIES:


  • Proactively manage operational aspects of assigned clinical study(ies) including management of timeline, budget, resources, and vendors
  • Oversee cross-functional study team (e.g., clinical services, data management, biostatistics, pharmacovigilance, central laboratory services)
  • Serve as the primary point of contact for study sponsors and lead recurring meetings
  • Lead study startup efforts (e.g., trial master file setup, site selection and initiation, IRB submission, negotiation of site and vendor agreement and budgets)
  • Develop and execute project plans (e.g. CMP, DMP, SMP) in accordance with study protocol, SOPs, ICH-GCP, US CFR, and other applicable regulatory requirements
  • Ensure external service providers execute activities in a quality manner and per the established contract
  • Ensure TMF filing, maintenance, and archival procedures are completed per SOPs
  • Escalate issues and potential study risks appropriately
  • Prepare for and participate in study audits and inspections
  • Identify study risks and issues, and develop mitigation strategies and CAPA plans
  • Create patient-facing and site-facing forms (e.g., ICFs, CRFs, ePRO)
  • Prepare materials for IRB submission and ensure initial and continuing approval
  • Track sites’ recruitment efforts and enrollment status of subjects
  • Train research staff in procedural aspects of studies (e.g., informed consent procedures, documentation procedures)
  • Assist with the coordination of data review with cross functional team to support database lock
  • Prepare updates for executive team and sponsors regarding study progress
  • Participate in subject recruitment and data monitoring activities as needed

KEY QUALIFICATIONS AND REQUIREMENTS:


  • Bachelor’s degree in biology, clinical research, project management or related field
  • Minimum of three years’ experience in a clinical research environment, including a minimum of two years’ working across multiple protocols
  • Experience with development of key clinical trial documents (e.g., CRFs, ICFs, recruitment materials)
  • Tech-savvy with the skills and ability to apply new systems to her/his everyday tasks
  • Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time
  • Ability to multitask proficiently across projects
  • Excellent oral and medical/technical writing skills
  • Ability to communicate effectively with sponsors/clients and team members
  • Strong interpersonal, leadership, and analytical skills
  • Ability to lead through influence without direct authority
  • Ability to demonstrate good judgement and decision making, attention to detail, and personal accountability

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About this role

Apply before

August 21st, 2021

Job posted on

March 15th, 2021

Job type

Full Time

Hiring timezones

Curebase is hiring for this role in the following timezones:

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Primary industry
Company size

11-50

Founded in

2017

Social media
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About the company

Curebase runs "distributed" clinical trials using a nationwide network of independent physicians and nurses. Our secret is a comprehensive software platform that bootstraps any qualified healthcare pro...
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