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Local Study Manager (home-based)

Employer
Hobson Prior
Location
Homeworking
Salary
£380 - £400 per day
Start date
2 Feb 2021
Closing date
26 Feb 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

Hobson Prior currently having an exciting opportunity for 2 Local Study Manager's to join a leading pharmaceutical organisation who provide pioneering medicines to patients all over the world. This is a contract position where you will be home-based.

Job Responsibilities:

  • Overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
  • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
  • Leads and optimises the performance of the Local Study Teams at country level ensuring compliance with the organisation's Procedural Documents, ICH-GCP and local regulations.
  • Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
  • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
  • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
  • Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in the organisation's clinical studies financial system by regular checks of the system and financial reports (as agreed with ADSMM/CH).
  • Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
  • Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations.
  • Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol.
  • Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
  • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
  • Any other assigned duties.

Key Skills:

  • Have the capability to prioritise and handle multiple tasks.
  • Exceptional attention to details.
  • Have excellent knowledge of spoken and written English.

Requirements:

  • Require's a bachelor's degree in life science, or equivalent qualification.
  • At least 3 years of experience in Development Operations or other related fields.
  • Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
  • Oncology experience is essential.
  • Previous experience as a CRA is essential.

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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