study protocol, SAP, ICF, etc.) and manage the review by in- and external teams + Oversee the preparation of regulatory submissions to the IRB/EC (local/ central) and national health authority(ies) for the assigned studies + Provide direction to study team members with a support role (CPCs and CTAs) + Monitor and track project progress to proactively identify risks to study timelines and budget, mitigation strategies and mitigate risks by implementing appropriate corrective and preventive actions, escalating as necessary + Ensure adequate oversight and management of clinical study sites by the CRO/monitors + Oversee process and aspects of timely data cleaning, data analysis and the reporting of headline results, manage and contribute to the data review process, tables/listing/figures review and development of the CSR + Proactively identify any issues or risks for the assigned studies and implement appropriate action and escalation of the issues + Ensure appropriate procedures are in place for timely reporting and adequate follow-up of SAEs to PHV, and subsequently to the authorities Other Responsibilities + Provide leadership, direction, and motivation to project team members, to promote their professional development + Prepare updates for senior leadership on the progress of study timelines/milestones, budget and resources, and summarize associated risks and risk mitigation plans + Provide updates and information related to assigned clinical stud(ies) to cross- functional departments, as needed (i.e. to PHV for periodic safety reports) + Participate in process improvement and quality related initiatives, such as review and/ or provide input and/ or write departmental SOPs, templates and forms **Qualifications** + Bachelor's degree or higher in a scientific or medical field preferred; work experience can be considered in lieu of degree + At least five years of experience in sponsor-side Clinical Project Management roles at small-to-mid sized biotech/pharma companies + At least two years of experience with global clinical trials + In depth knowledge of ICH-GCP and regulatory requirements + Ability to work across multiple time zones, including Europe + Strong knowledge of protocol and clinical drug development processes, monitoring, clinical study planning, conduct and management + Requires project management skills and study leadership ability + Must have excellent interpersonal, written and verbal communication skills + Excellent time management skills **Salary Range** Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level. **Responsibilities** Clinical Studies + Coordinate with cross-functional teams during the clinical study development phase to ensure there are appropriate internal resources, IMP and sufficient budget for the conduct of the clinical study + Oversee project level operational aspects of the clinical study, including development and management of study timelines, budget and deliverables + Lead the selection, contracting and budget negotiations of CROs, other third-party vendors and clinical trial sites + Plan and implement the development of essential study documents (e.g.