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Clinical Research Study Leader

Employer
Hobson Prior
Location
Welwyn Garden City, England, Hertfordshire
Salary
Negotiable
Start date
21 Jul 2021
Closing date
18 Aug 2021

View more

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

Job Details

A new 12-month contract vacancy has opened for a Clinical Research Study Leader to join a world-wide pharmaceutical organisation focused on the research and development of novel medicines and marketing them once they have been developed. This position will lead the cross-functional Study Management Team

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

Key Responsibilities:

  • Responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal setting.
  • Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.
  • Recognises key milestones and tracks critical study activities, issues and strategic priorities.
  • With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives.
  • Conducts protocol and site feasibility assessments to ensure optimal site selection.
  • Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.
  • Proactive management of all aspects of the study.
  • Manages both internal and external partners.
  • Any other assigned duties.

Key Skills:

  • Highly developed interpersonal skills and demonstrated business awareness.
  • Effective leadership skill to lead cross-functional teams across multiple time zones.
  • Highly effective verbal and written communication/presentation skills in English.
  • Effective teamwork and interpersonal skills (globally, internally and externally) including coaching and mentoring.
  • Critical reasoning skills including the identification and resolution of complex problems.

Requirements:

  • Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline.
  • Study management experience in clinical or pharmaceutical development.
  • Working knowledge of international regulatory and ICH GCP guidelines.
  • CRSL II will be required to have extensive experience leading Phase I and Phase II studies.
  • Experience in Phase I or Phase II studies, but are not required to have specific therapeutic area experience.
  • Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with preference for early phase studies).
  • Sound understanding and appreciation of the scientific basis for different study types.
  • Capability representing the Study Management Group at Clinical Teams.
  • Proactive management of risk mitigation strategies to troubleshoot foreseeable consequences to a variety of decisions made by a team or an individual.
  • Direct experience overseeing multiple vendors and sites.
  • Willingness to travel internationally.

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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