Clinical Project Manager - US

Negotiable
  1. Permanent
Boston, Massachusetts
  1. Clinical Operations, Project Management
Posted:19/04/2021
BBBH16362

Hobson Prior are currently working with a clinical-stage biotech organisation whose passion is to work together as one team and noticeably making life changing impact. Our client is seeking a Clinical Project Manager for an exciting permanent position based in the US.

Job Responsibilities
:

  • Accountable to lead the planning and execution of clinical studies from Phase I to IV in adherence to Good Clinical Practice, Standard Operating Procedures, Food and Drug Administration regulations, EU Directives & Guidance, and International Conference on Harmonisation guidelines.
  • Lead site selection and site qualification discussions with project team and CRO.
  • To ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed by the Project Team.
  • Lead document writing and review for the protocol and amendments, Investigator brochure and Clinical Study Report. Additional medical writing tasks may involve ICF, CRF and associated guidelines, safety communications, DSUR and additional key documents.
  • Lead the study team meetings.
  • Lead the creation of the Trial Oversight Plan and ensure adherence. CRO and Quality Oversight
  • Ensure CRO selection is appropriate for the study planned.
  • Validate the study plans provided by the CRO through to study close out.
  • Accountable for management of CRO performance to ensure adherence to scope of work within timelines and budget at an overall study level.
  • Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study.
  • Recognise issues early and propose solutions.
  • Any other assigned duties.

Key Skills:

  • Robust oral and written communication skills.
  • Highly organised and able to plan, prioritise and manage time efficiently.
  • Collaborative working style with ability to partner across the organisation.
  • Self-motivated and able to work self-sufficiently.

Requirements:

  • Degree in a relevant discipline.
  • At least 5+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at national and international level.
  • Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development including.
  • Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines.
  • Strong scientific, operational, and regulatory expertise.
  • Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices.
  • Ability to communicate effectively, including with therapy area experts and patient advocacy groups.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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