Real World Data

3 months ago

Weybridge, United Kingdom Clinigen Full time

Clinigen 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 global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly and is positioned well for an exciting future of continued expansion.

**The Role**:
As a member of the Clinigen Real World Data team, this role has responsibility for supporting the Real World Data Managers with delivery, maintenance and closure activities associated with our pharmaceutical clients RWD programs which are part of selected Clinigen Managed Access Programs.

**Key Responsibilities**:

- To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedure

**Reflection & Organisation**
- 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 Standard Operating Procedures (SOP) and work instructions.
- Create program documentation and maintain until program closure.
- If applicable, track vendor invoices and ensure all client invoices are raised on a monthly basis.
- Monitor the financial status of assigned programs.
- Support internal teams with program related queries and escalate issue as appropriate
- 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.

**Communication**
- 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.
- Maintain excellence in Client Relationships and Service Delivery
- Act as a point of contact for individual client and client affiliate teams for discontinuation queries, as appropriate.
- Support Program Managers (PM) in the management of change to existing discontinuation programs
- Attend meetings and create clear, concise and accurate minutes of discussions, decisions and actions.

**Analytics/Technical**
- Support the RWD Manager in program set-up activities including but not limited to eCRF design, database set-up, user acceptance testing (UAT).
- Support the creation of Client reports as per contractual agreements with the clients.

**Data Management**
- Perform discontinuation activities for assigned programs, including set-up, quality checking and provision of discontinuation tracker to clients.
- Perform data entry, data review, data quality checks, query management and monthly safety reconciliation until program closure.
- Monitoring of safety information on an ongoing basis and ensuring this is reported to the drug safety team.

**People**
- Assist in induction of new members of staff entering the role.

**Health and Safety Responsibilities**:

- The Management of Health and Safety at Work Regulations 1992 re-enacts the Health and Safety at Work etc. Act 1974, which places responsibilities on the employer and employees alike. In connection to this, the Company reminds employees of their duties under Section 7 of the act:

- To take care for their own health and safety and that of others who may be affected by their acts or omissions. Additionally, employees must also co-operate with the company to enable it to discharge its own responsibilities successfully.

**Furthermore, all employees must**:

- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with safety rules/procedures, regulations and codes of practice
- If aware of any unsafe practice or condition, or if in any doubt about the safety of any situation, consult their Line Manager
- Obtain and use the correct tools/equipment for the work and not to use any that are unsafe or damaged. All tools, equipment and personal protective equipment must be stored in the approved place after use
- Ensure that all guards are securely fixed and that all safety equipment and personal protective clothing/equipment provided are used
- Not to operate any plant or equipment unless authorised
- To report any accident, near-miss, dangerous occurrence or dangerous condition to their Line Manager
- To switch off and secure unattended plant or equipment
- To avoid improvised arrangements and suggest safe ways of eliminating hazards
- Not to participate in horseplay or place fellow employees in danger by their actions

**General Responsibilities**:

- Champion the Clinigen Way principles which underpin everything we do, living those values in daily Clinigen life
- Know Clinigen’s strategy and ensure what you do on a day to day basis is in line with those strat

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