Clinical Trial Manager

Job Description

Job Title:      Clinical Trial Manager

Reports To:  Associate Director, Clinical Operations

Location:       Boston, MA

Position Summary:

Reporting to the Associate Director, Clinical Operations, the Clinical Trial Manager will be responsible for all operational aspects of a clinical trial from study planning activities to study execution and close out, including support for the Global Operations Lead in the management and oversight of the lead phase 3 program

What makes this role special:

  • Seek to have a profound impact on young children and their families
  • Potentially be part of the first launch of a medicine for a rare pediatric liver disease
  • Work on a portfolio of multiple potential therapies
  • Gain a rare diversity of commercial experience
  • Develop strategy, as well as manage execution
  • Help shape the culture and future of an emerging biopharma with a big vision
  • Collaborate with a small, collegial team of good people
  • Learn from leadership with deep experience and a history of success
  • Be part of an early biopharma company in an excellent financial position
  • Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment  

Responsibilities (may vary):

This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee

Key Duties and Responsibilities:

  • Collaborate with, and manage, the CRO functional teams to deliver on time, within budget and with quality
  • Support vendor oversight for additional third-party vendors, including laboratories, IXRS, EDC, ePRO and central imaging, as needed
  • Define and track performance metrics and quality indicators
  • Maintain and provide information for monthly study status and risks/mitigation strategies (including enrollment curves and timelines) for reporting to senior management
  • Provide operational input for study documents, such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Study Reference Manual, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc
  • Contribute to subject recruitment/retention strategy and related initiatives
  • Manage countries/regions for site activation, CRA and site support during study maintenance, conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP as needed, and support the study close-out and database lock activities
  • Participate in study data review, and assist with patient narrative writing and other data review activities
  • Contribute to the TMF set-up, ongoing quality and completeness review, and final reconciliation of study documents, including review of site regulatory documents/packages
  • Serve as an escalation point and resource for internal/external teams and investigational sites; partner with cross-functional groups to achieve deliverables
  • Ensure that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct  

Qualifications:

  • BA/BS/RN in science or health-related field
  • Minimum 3-5 years clinical trial management experience in biotech/pharma/CRO
  • Working knowledge of GCP, ICH and FDA regulations
  • Strong study management track record showing clear proficiency in clinical project management, including vendor management
  • Experience interfacing with key medical personnel at clinical site(s)
  • Prior monitoring of clinical trial sites
  • Participation in a cross-functional project team
  • Familiarity with clinical data management, DSMB and biostatistics/programming processes preferred
  • Experience in rare/orphan diseases and/or pediatric clinical trials a plus
  • Demonstrated detailed understanding of clinical protocol and intended study populations, as well as solid overall drug development
  • Demonstrated ability to effectively interface with key medical personnel at clinical site(s)
  • Demonstrated ability to flag processes that may not be appropriate for study based on phase, design and/or use of data
  • Ability to travel up to 25% of the time; both domestic and international

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

All applicants should be legally entitled to work for any employer in the U.S.

Note to employment agencies: Please do not forward any agency resumes.  Albireo is not responsible for any fees related to resumes that are unsolicited.