[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.ResponsibilitiesCoordinate 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 studyOversee project level operational aspects of the clinical study, including development and management of study timelines, budget and deliverablesLead the selection, contracting and budget negotiations of CROs, other third-party vendors and clinical trial sitesPlan and implement the development of essential study documents (e.g. study protocol, SAP, ICF, etc.) and manage the review by in- and external teamsOversee the preparation of regulatory submissions to the IRB/EC (local/ central) and national health authority(ies) for the assigned studiesProvide 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 necessaryEnsure adequate oversight and management of clinical study sites by the CRO/monitorsOversee 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 CSRProactively identify any issues or risks for the assigned studies and implement appropriate action and escalation of the issuesEnsure appropriate procedures are in place for timely reporting and adequate follow-up of SAEs to PHV, and subsequently to the authoritiesProvide leadership, direction, and motivation to project team members, to promote their professional developmentPrepare updates for senior leadership on the progress of study timelines/milestones, budget and resources, and summarize associated risks and risk mitigation plansProvide 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 formsSkillsBachelor's degree or higher in a scientific or medical field preferred; work experience can be considered in lieu of degreeAt least five years of experience in sponsor-side Clinical Project Management roles at small-to-mid sized biotech/pharma companiesAt least two years of experience with global clinical trialsIn depth knowledge of ICH-GCP and regulatory requirementsAbility to work across multiple time zones, including EuropeStrong knowledge of protocol and clinical drug development processes, monitoring, clinical study planning, conduct and managementRequires project management skills and study leadership abilityMust have excellent interpersonal, written and verbal communication skillsExcellent time management skillsBenefitsA fully remote work scheduleCompetitive compensation package including annual target bonusLong-term incentive program401(k) plan with company matchPaid Time Off (PTO)13 Company Holidays per yearExcellent benefit plans including medical, dental, and visionFlexible spending accountsCompany-provided life insurance, short-term disability, and long-term disability plansOptional accident, hospital indemnity, critical illness, and pet insurance plansTuition reimbursement programHealth and wellness programChoice of company provided mobile phone or cell phone stipendCompany OverviewOverview Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. It was founded in 1988, and is headquartered in Leiden, Zuid-Holland, NLD, with a workforce of 51-200 employees. Its website is https://www.pharming.com.