CROMSOURCE

Clinical Trials Disclosure Lead, United Kingdom - L

Company
CROMSOURCE
Location
United Kingdom
Salary
Competitive
Posted
05 Feb 2021
Closes
24 Feb 2021
Ref
HQ00002447
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Trials Disclosure Lead, to join our client-based team. This is for one of the leading global biopharmaceutical companies, with a focus on Neurology and Immunology.

Scope of the role:

As a Clinical Trials Disclosure Lead, you like to work in an environment where you can combine scientific data handling, cross-functional project management, and communication to deliver compliant and responsible disclosure of Company-sponsored clinical trial information on clinical trial registries and other public internet platforms, for the ultimate benefit of patients.

Job specific tasks and responsibilities:

As a Clinical Trials Disclosure Lead
  • Managing the timely disclosure of trial protocol & results information on major clinical trial registries such as ClinicalTrials.gov, from disclosure planning to data entry & cross-functional review/approval to submission & release
  • Keeping study records on registries up-to-date at all times - in line with legal obligations, and maintaining complete, accurate & consistent records across internal tracking systems & archiving platforms
  • Supporting local teams/partners (responsible for data entry into local registries) by providing approved master/core disclosure content, to ensure consistency of disclosed trial information across registries worldwide


As Subject Matter Expert in clinical trial disclosure
  • Developing & maintaining effective working relationships with interfacing stakeholder groups, and providing them with relevant training & updates on clinical data disclosure & related processes


Education and Experience:
  • Master's degree in Life Sciences
  • At least 1 year relevant experience with clinical development, preferably trial &/or data management, biostatistics or regulatory affairs
  • Experience in clinical trial disclosure is a clear plus
  • Experience with / capability to identify, evaluate & apply relevant regulations & guidelines applicable to clinical research and more specifically to clinical trial disclosure, including e.g., FDA & EMA regulations & ICH/GCP


Skills:
  • Strong project planning & organizational skills
  • Ability to manage multiple responsibilities in an environment of changing priorities without close supervision
  • Proactive & flexible approach, drive & follow-through
  • Data-driven & attention to detail
  • Ability to evaluate technical matters & build process efficiencies
  • Excellent communication/interpersonal skills
  • Ability to work effectively with multidisciplinary & international teams
  • Excellent English verbal & written communication
  • Ability to deliver presentations & training
  • Strong computer skills - proficiency in MS Office; comfortable with using data/document management systems; knowledge of disclosure management systems such as PharmaCM / TrialScope Disclose is a clear plus


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002447

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Trials Disclosure Lead
Skills: Neurology, Biostatistics, Clinical Data Management, ICH-GCP, Immunology, Regulatory Location: United Kingdom Share:

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