Job Description
An opportunity has opened to support one of our established Pharma client's Global Clinical Trial Transparency disclosure operations in a 12 month, FTC (fixed term contract). You'll ensure compliance with the disclosure processes which support the company's Policy for Clinical Trial Transparency and applicable regulations. Demonstrating success supporting the activities of GCTT team members assigned to disclosure operations, working collaboratively and independently as required, with internal and external team members to ensure the company's Global Clinical Trial Transparency disclosure responsibilities are achieved.
Apply below after reading through all the details and supporting information regarding this job opportunity.
Duties/ responsibilities
* Performing/coordinating all activities to meet disclosure obligations (registration, maintenance, and results posting on ClinicalTrials.gov and clinicaltrialsregistry.eu and any other applicable repositories) in a timely manner.
* Support the activities of the GCTT team members assigned to disclosure operations ensuring they follow process, understand disclosure rules and regulations, and work as a team to meet disclosure obligations (registration, maintenance, and results posting on ClinicalTrials.gov and clinicaltrialsregistry.eu and any other applicable repositories) in a timely manner.
* Working closely with the internal team and vendor(s) to ensure they are fully aware of their roles and responsibilities related to the company's Clinical Trial Transparency disclosure obligations.
* Working closely with the vendors to ensure that the company's Clinical Trial Transparency disclosure obligations are performed in compliance with policy, procedures, and applicable regulations.
* Contribute to the assessment and selection of Vendors for disclosure systems and services, as required.
* Support and contribute to, as an SME, the implementation and upgrade of the disclosure system, as delegated by the Head of GCTT, from initiation to deployment.
* Contributing to the regular assessment of GCTT disclosure activities for risk, and that any risks identified are tracked, managed, and potential mitigation and implementation strategies are developed.
* Preparing training materials and delivering training on end-to-end disclosure operations process, important process changes, and other associated topics to all the stakeholders involved.
* Contribute to raising awareness of clinical trial disclosure and its changing requirements within the company globally, as required.
* Maintain awareness of existing and emerging guidance on public disclosure processes, requirements and information, including EMA, FDA and international regulatory requirements for registration, results posting content and format.
* Contribute to the interpretation and assessment of the impact of emerging clinical trials disclosure regulations and applicable laws, to maintain compliance for their impact on daily operations by proposing and implementing appropriate process changes, and generally assessing the GCTT operations processes to identify opportunities for improvements.
* Representing the company within industry working groups, association forums associated with disclosure operations, as required.
* Supporting other clinical transparency activities within GCTT as required.
Tools and equipment used/ working environment
* Work will be mainly office-based in an open plan environment with flexibility to work from home, adhering to the company rules (2-3 days office working in Hertfordshire)
* Software/computer systems used mainly include:
o MS Office, especially MS Excel.
o Sharepoint.
o Document Management System (Documentum).
o Company's Clinical Trials Disclosure Management System.
o Data entry portals for publicly accessible registries.
o Vendor platforms and databases.
o Readsoft.
Working relationships
* The position does not have line management responsibilities.
* Internal: close collaboration with company departments worldwide managing studies, such as regulatory leads, clinical operations, and local affiliates (EU, US, Japan, China, other Asian countries), Legal (including Intellectual Property), other internal departments, as required, to support development and implementation of GCTT procedures and systems.
* External: close collaboration with an external vendors, FDA, EMA and other authorities overseeing local registries, and other pharmaceutical representatives on industry working groups and forums.
Education and experience required:
* Education to B.Sc. level or equivalent.
* Understanding of clinical development within the pharmaceutical industry.
* Demonstrated experience in the pharmaceutical industry, and a SME within the clinical trial disclosure area.
* Working knowledge of industry tools and solutions for study registration and results disclosure.
What's on offer? A competitive basic salary + bonus, healthcare, life insurance etc.
For more information, please apply.
If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill on j.oneill@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.