[Remote] Senior Clinical Project Manager Job Details | Pharming Group N.V.

Note: The job is a remote job and is open to candidates in USA. Pharming Healthcare, Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare diseases. The Senior Clinical Project Manager is responsible for planning, initiating, executing, and reporting assigned clinical studies, overseeing project operations, and coordinating with cross-functional teams to ensure successful study outcomes.

Responsibilities

• 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. 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
• 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

Skills

• 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

Benefits

• A fully remote work schedule
• Competitive compensation package including annual target bonus
• Long-term incentive program
• 401(k) plan with company match
• Paid Time Off (PTO)
• 13 Company Holidays per year
• Excellent benefit plans including medical, dental, and vision
• Flexible spending accounts
• Company-provided life insurance, short-term disability, and long-term disability plans
• Optional accident, hospital indemnity, critical illness, and pet insurance plans
• Tuition reimbursement program
• Health and wellness program
• Choice of company provided mobile phone or cell phone stipend

Company Overview