Real World Data Co Ordinator
3 weeks ago
ORGANISATION
Clinigen Limited is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world.
We are currently 1,100 people, headquartered in the UK, with sites in Burton-on-Trent and Weybridge, with global offices in the US, EU, Australia, New Zealand, Japan, Hong Kong, South Africa, and South East Asia. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued growth. To sustain our growth, we’re on the lookout for motivated, ambitious and committed individuals to join our highly successful global team.
ROLE
A member of the Real World Data team, having responsibility for supporting the Real World Data Specialists and Data Managers with delivery, maintenance and closure activities associated with RWD databases.
**Key Responsibilities**:
- Adhere to regulatory, quality and compliance guidelines and appropriate level of SOP competence measured against Clinigen’s quality standards.
- Support RWD team in the creation of SOPs and work instructions.
- Monitoring of reported Drug safety information and ensuring it is reported to drug safety team.
- During the course of the program, interact with the wider Clinigen Managed Access team, Pharmaceutical / biotech / medical device clients, external vendors and Pharmacists/Physicians participating in Clinigen Managed access program (MAP) on a regular basis.
- Support the creation of Client reports as per contractual agreements with the clients.
- Support the RWD specialist in program set-up activities. including but not limited to eCRF design, database set-up, user acceptance testing (UAT).
- Create program documentation and maintain until program closure.
- Engage with HCPs regarding account activation status to ensure data entry compliance.
- Regularly follow up with HCPs for RWD platform account activation, data entry and discontinuation data.
- Perform discontinuation activities for assigned programs, including set-up, provision of discontinuation tracker to clients.
- Review data on an ongoing basis and perform ongoing data cleaning activities until program closure.
**REQUIREMENTS**:
- Relevant science degree.
- Experience working in the pharmaceutical/life sciences industry.
- Proficient in Excel and experience with EDC or other data collection tools
- Strong interpersonal and oral and written communication skills
- Demonstrable track record of ability to multitask and prioritize as well as communicate deliverable status.
- Proactive and solutions-driven
- Ability to build strong working relationships with internal and external stakeholders to collaborate effectively on projects with mutually beneficial outcomes.
- Willingness to learn new tasks, tools and processes.
**BENEFITS**:
- 27 days holiday plus bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
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