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Global Studies Manager - I2ON (remote-based)

Employer
Hobson Prior
Location
Hertfordshire, England, Welwyn Garden City
Salary
GBP490 - GBP500 per day
Start date
23 Sep 2021
Closing date
21 Oct 2021

View more

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

Job Details

A new 12-month contract vacancy has opened for a Global Studies Manager - I20N to join a world-wide pharmaceutical organisation focused on the research and development of novel medicines and marketing them once they have been developed. In this role, you have the opportunity to work fully remotely or have a home/office split.

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

Key Responsibilities:

  • In this role, you will be responsible for providing direction and leadership to one or more global Study Management Teams (SMTs).
  • Developing operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
  • Building and maintaining effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities, and deliverables.
  • Creates a team culture and promotes team spirit.
  • Contributes to the development and management of the study timelines, budget, risk and quality plans.
  • Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Global Studies Leader (GSL).
  • Develops and manages clinical study budgets (including HQ budget). Communicates variances in the budget and action plan for resolution to the GSL.
  • Provides clinical operations expertise to ensure operational feasibility and delivery.
  • Leads the development and finalization of site feasibility questionnaires.
  • Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and Operational Program Leader (OPL).
  • Oversees forecasting of clinical/non-clinical supplies.
  • Designs drug assumption and supply chain process in partnership with Drug Supplies, affiliates and GSL.
  • Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
  • Delivers the operational elements of the study plan.
  • Chairs operations team meeting and organizes investigator meetings, monitor training, CRO kick-off meetings.
  • Ensures that reporting process of SUSARs is established and maintained for the duration of the study.
  • Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with key stakeholders.
  • Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work.
  • Performs ongoing vendor management (e.g., CROs, Central Labs, IxRS, etc.), including negotiation of scope of work, budgets, performance management, and issue resolution.
  • Develops and supports appropriate site and CRO/vendor audit and quality plans.
  • Identifies areas of best practice and process improvements.
  • Participates in Product Development Global Operations initiatives and programs as assigned.
  • Maintains oversight and ensures consistency of the operational aspects across studies within a project.
  • Any other assigned duties.

Key Skills:

  • Strong attention to detail.
  • Proficient computer skills.
  • Outstanding written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organisation.

Requirements:

  • The ideal candidate will have strong experience of project managing operational aspects of a clinical study including development and management of timelines and budgets.
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
  • Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
  • Good knowledge of ICH GCP.
  • Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.

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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