Manager, Clinical Research Study Lead (Remote)

at Xcenda / AmerisourceBergen (view profile)
Location Anywhere, United States of America
Date Posted July 7, 2022
Category Clinical Operations
Job Type Full-time
Job Level Manager or Senior Manager
Sponsorship available? Yes
Other Locations United States

Description

Are you looking to make a difference in a patient’s life?  At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

As of August 24, 2021, AmerisourceBergen requires all U.S. team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a disability/medical reason or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation.

This is a remote role for US-based candidates.

POSITION SUMMARY:

The Manager, Clinical Research Study Lead is responsible for the design, execution and conduct of clinical research studies in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Standard Operating Procedures.
PRIMARY DUTIES AND RESPONSIBILITIES:

The responsibilities of the position may include, but are not limited to, the following:

  • Overall leadership of clinical studies from inception through close-out with accountability for all milestones and deliverables
  • Develops protocols, clinical study reports and all study-related content
  • Leads internal study team to ensure achievement of milestones and deliverables
  • Leads client meetings including preparation of agendas and minutes
  • Prepares and manages study timelines
  • Manages all study financials including resourcing, allocating of backlog and tracking
  • Develops and manages sites budget and negotiates contracts
  • Reviews site feasibility assessments and monitoring reports
  • Designs ICF templates, CRFs, procedure manuals, and other project-specific documents
  • Performs testing for electronic data capture (EDC) system.
  • Oversight of the coordination of IRB submissions, amendments, and annual updates
  • Tracks patient enrollment targets and works with study team on strategies to ensure targets are achieved
  • Verifies appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements
  • Ensures overall study adherence to the protocol and applicable regulations and SOPs
  • Development of SOPs
  • Conducts in-person and remote monitoring visits and prepares visit reports as needed
  • Ongoing identification of new business development opportunities resulting in contracted work
  • Development of presentations and proposals in in response to RFPs received from clients
  • Lead new business development opportunities and capability presentations
  • Other duties as assigned

What your background should look like 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

  • Bachelor’s degree in life-sciences or related field
  • Minimum of 7 years clinical research experience including leadership positions in the pharmaceutical or medical device industry
  • Strong working knowledge of GCPs and Federal Regulations
  • High level of organization and self-motivated to manage multiples sites and projects simultaneously
  • Direct and broad experience with all aspects of clinical operations is required
  • Experience in a fast paced CRO or start-up pharmaceutical company is preferred
  • Proficiency in MS Word, MS Excel, MS PowerPoint
  • Excellent written and oral communication skills

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • Work independently and proactively
  • Strong organizational skills
  • Detail oriented
  • Strong work ethic
  • Positive attitude
  • Functions as a team player
  • Works efficiently on all tasks within the allotted number of hours by deadline
  • Excellent verbal and written communication skills
  • Ability to manage a diverse project load
  • Produce positive results in a high-pressure environment
  • Prioritize tasks and complete assignments in a thorough and competent manner
  • Recognize areas to increase efficiency and contribute solutions
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