Ref #: 26401

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 15-Feb-2021

Description

Insurance, Delegation of Authority & Sponsorship Compliance (IDSC) Specialist

This position is accountable for the success and execution of assigned/delegated tasks to support Insurance, Delegation of Authority & Sponsorship Compliance (IDSC) activities in management of global clinical trials within agreed timelines and expected level of quality, in alignment with all the applicable SOPs and regulatory requirements, with support and oversight.


PRINCIPAL RESPONSIBILITIES:

• Performs the day-to-day IDSC activities, with oversight and guidance from senior level staff in accordance with internal standard operating procedures, global health authority regulations and good clinical practices.
• Performs assessments of clinical study protocols against insurance policy exclusions to ensure there are no potential conflicts with the insurance policies.
• Process requests for clinical trial insurance and collaborate with broker/insurer to provide finalized insurance documentation for EC/HA submissions.
• Draft and finalize delegation documentation based on approved general, country-specific, or CRO templates, as applicable, based on the structure of the trial
• Review and approve documentation related to JCI /JBV sponsorship of clinical trials, according to GCO SOPs
• Respond to questions from stakeholders relating to specific requests & IDSC processes and requirements
• Contributes to Ethical Committee (EC) and HA responses and queries for assigned area of responsibility
• Assists in the gathering and maintenance of intelligence information and document templates in support of IDSC activities.
• Captures data, as applicable, to track day-to-day activities
• In collaboration with senior level staff, supports development of training and awareness sessions to internal and external partners and stakeholders.
• Contributes to process improvement initiatives
• Contributes information required for Health Authority (HA) inspections and internal Quality Assurance (QA) audits.
• This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

PRINCIPAL RELATIONSHIPS: Describe the primary working relationships (internal & external) and primary interfaces.
Contacts inside the company may include:
Study team members from PDO & GCO, Clinical, Legal, Risk Management, JCI/JBV Board Members, Finance, Global Regulatory Affairs, Contract Specialists, NCC Office, IT, eBIS across all Therapeutic Areas within the Research and Development/Operating Company.
Contacts outside the company may include: Global Insurer, Insurance Broker, Clinical Research Organizations, vendors

EDUCATION AND EXPERIENCE REQUIREMENTS:
• Bachelors degree or equivalent preferred (preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy)) or business experience .
• Minimum of 2-4 years experience in the pharmaceutical industry or CRO (or equivalent) required.
• Working knowledge of the clinical development process is preferred.
• Excellent communication skills (both oral and written) required.
• Ability to work effectively in cross-functional teams, participating on global teams in a virtual environment.
• Strong organizational skills, ability to prioritize and accomplish a large volume of work required.
• Ability to contribute to the productivity and cohesiveness of the team required.
• Fluency in English is required.

This would also suit someone of who has strong Global CTA experience within Pharma or CRO and has taken on experience working with insurance and compliance within a Pharma or CRO setting

Please note that you MUST be located in UK and have a valid right to work in the UK without the need of Sponsorship.