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Clinical Project Manager - US

Employer
Hobson Prior
Location
Massachusetts, Boston, USA
Salary
Negotiable
Start date
19 Apr 2021
Closing date
14 May 2021

View more

Discipline
Project Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

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.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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