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Clinical Project Manager

Employer
Hobson Prior
Location
England, London
Salary
GBP80 - GBP90 per hour
Start date
25 Nov 2021
Closing date
7 Dec 2021

View more

Discipline
Clinical Research, Clinical Program Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Hobson Prior are looking for a Clinical Project Manager to join a leading pharmaceutical organisation who focuses on transforming the lives of people living with a life debilitating disease. This role will be on contract basis and located in the UK.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs/Phase 1 Units and other vendors.
  • Collaborate with members of Clinical Study Team / Joint Clinical Study teams to develop clinical trial protocols, protocol amendments, and other relevant study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.
  • Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate).
  • Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings.
  • Support Data cleaning and data evaluation meetings and Results Interpretation Meetings.
  • Support conduct of Data Monitoring Committee Safety Monitoring Committee review meetings.
  • Ensure that Clinical Study Reports meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.
  • Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members.
  • Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices.
  • Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
  • Asia Specific - support any Regulatory Authority consultation activities.sm
  • Provide study specific training for internal and external team members.
  • Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.
  • Visit investigational sites and Phase 1 Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrolment, when needed for assigned clinical studies.
  • Travel including overnight stays- possibly global - required.
  • A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience as appropriate.
  • A Senior CPM may be assigned to more complex studies and those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel.
  • Perform other tasks as deemed necessary by the Company.

Key Skills:

  • Good interpersonal skills.
  • Excellent time management and organizational skills.
  • Negotiation skills.

Requirements:

  • At least three years' relevant experience in clinical development including team leadership.
  • Experience or capability to manage in-house and outsourced regional or global Phase 1, 2 or 3 studies from study start-up to study report completion.
  • Must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.
  • Clinical trial management in Early and Late Phase and team leadership.
  • Motivation, mentoring and integration of individuals on multi-functional international teams.
  • Delivery of scientific presentations and training to both large and small audiences.

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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