Job overview
The Senior Clinical Research Manager is responsible for planning, setup, conduct, close-out, reporting and archiving of clinical research trials according to applicable international, local and company defined standards.
Responsibilities and duties
- Lead the execution of clinical trials to agreed timelines, budget and in compliance with the clinical study protocols(s), international guidelines for Good Clinical Practice, GDPR, applicable SOPs and local procedures and regulations.
- Planning of clinical research activities and ensure alignment with vendors and the internal organisation, where applicable.
- Delivering high quality clinical research data and full study documentation (incl. (e)TMF
- Setting up efficient working relationships with external providers / vendors
- Keeping the Orphalan organisation adequately informed about progress and issues of the ongoing trial(s)
- Collaborate effectively with other key stakeholders and functions both internally and externally to deliver successful trial execution.
- Contributing to periodic financial analyses, regarding costs (incl. approved and expected invoices) and budgets.
- Lead the evaluation, selection and management of third-party vendors (e.g. Contract Research Organisations (CROs) and other external vendors) to ensure successful clinical trial implementation and execution.
- Drive the development and operational input into MSAs/Wos/CTAs/TAs.
- Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
- Ensure development of and, as appropriate, author components of key study documents such as clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary.
- Develop and execute risk assessment strategies for each trial. Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including issue escalation and resolution.
- Involved in the implementation of QC activities, to ensure compliance with quality measures and to monitor required quality metrics across the studies being run within clinical operations.
- Providing input on SOP development for clinical operations and companywide procedures as appropriate.
Requirements
Bachelor or master’s degree in life sciences, with at least 10 years’ experience in clinical research of which at least 5 years in clinical study management in pharmaceutical or biotech industries.
- Knowledge and understanding of project management, analysis of study performance indicators (regulatory approvals, site selection, site initiation, patient enrolment, patient performance, etc.), interpretation of scientific results.
- In depth knowledge of GCP and current legislation supporting clinical research.
- Previous participation in regulatory authority inspections/audits.
- Team oriented attitude with the ability to steer a team and having strong interpersonal relationship skills.
- Highly organised and structured personality.
- Advanced English language skills in writing and speech.
Location and travel:
- Hybrid
- Willingness to travel abroad/intercontinental as required (3 to 6 times per year)