Senior Clinical Data Manager
hace 1 día
Warren
About Pharming PharmingHealthcare Inc.is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, witha significant proportionof its employees based in the U.S. Our Vision Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets,leveragingproven and efficient clinical development, supply chain, and commercial infrastructure. #Life at Pharming Today, more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, #Life at Pharming, which is dynamic, experimental, and shaped by what we learn together. We are looking for people who are excited about our vision and living our values: • We put Patients at the heart, • We act with urgency, • We make it simple, • We get it done Summary The Senior Clinical Data Manager (Sr. CDM) serves as the primary inhouse data management expert within a near-to-fully outsourced clinical execution model. This role provides strategic oversight and handson leadership of all data management activities across the development programs in the Pharming portfolio. This includes building fit for purpose data capture systems, database cleaning, and coordination of third-party data transfers to facilitate trial reporting. The Sr. CDM will work closely with our CROs and vendors who prosecute these activities and with the internal/external biostatistics team and importantly will be an integral part of our matrixed clinical development teams. The goal of this role will be to ensure timely, accurate, and compliant data delivery across the Pharming portfolio. The Sr. CDM ensures endtoend data quality, SDTM/ADaM traceability, and the accuracy of all statistical outputs, including tables, listings, and figures (TLFs), that support interim analyses, topline readouts, and regulatory filings. Responsibilities General Clinical Data Management and Data Related Vendor Oversight: • Provide expert guidance on data implications for protocol design, endpoints, and operational feasibility., • Act as the primary liaison between Pharming and vendor data management and biostatistics teams., • Review and approve CRO plans, including Data Management Plans, CRF completion guidelines, edit check specifications, and data review plans., • Oversee CRO and vendor performance, ensuring adherence to timelines, data quality standards, and contractual deliverables., • Partner closely with Clinical team members, Safety and Regulatory to ensure crossfunctional alignment on data strategy. Other Responsibilites: • Support the development of study-specific database builds using study protocol and configuration specifications, including performance of the User Acceptance Testing (UAT)., • Review SAPs and TLF mock shells for feasibility, completeness, and alignment with collected data, and ensure complete endtoend traceability: CRF SDTM ADaM TLF outputs., • Periodically conduct targeted QC of key listings (e.g., AEs, SAEs, ConMeds, labs, vitals, exposure, efficacy assessments) to identify outliers, missing data, unexpected patterns, and data inconsistencies; drive their resolution with CROs., • Manage clinical data cleaning and delivery activities, including (soft)database lock, for interim analyses, DMC/DSMB reviews, and final CSR., • Ensure all data cut and database lock criteria are met and documented., • Ensure alignment between data management findings and statistical programming outputs., • Ensure AE/SAE data quality, including reconciliation with safety narratives and coding consistency (e.g., MedDRA)., • Validate treatmentemergent flags, exposure metrics, and safety population definitions produced by CRO partners., • Lead TFL review workshops and data review meetings with Medical, Safety, and Clinical Ops., • Manage adhoc biostatistics and data requests from Health Authorities (e.g., FDA, EMA) during NDA/BLA review and coordinate rapidturnaround analyses and data outputs with CRO Biostats/Programming., • Support data output and review for medical and scientific presentations/publications., • Collaborate with Regulatory Affairs to track requests, ensure timely responses, and document resolutions., • Drive both strategy and delivery of all data management related items., • Other duties as assigned. Qualifications • At least 6 years of clinical data management experience in the pharmaceutical/biotech industry, preferably in a small biotech., • Bachelor's or Master's degree in a scientific or technical discipline., • Expertise with EDC systems (e.g., Rave, Veeva, Inform) and vendor data pipelines., • Solid understanding of SAS outputs, derivations, and dataset structures (SAS programming experience a plus but not required)., • Proficiency with CDISC standards, Pinnacle 21, and submission metadata tools., • Experience using AI tools to enhance work product and increase efficiency., • Proven experience overseeing outsourced DM/Biostats activities., • Experience supporting regulatory submissions (NDA/BLA) preferred., • Commitment and alignment to Pharming's mission, core values and behaviors. Salary Range The base salary range for this job is from $130,000 to $170,000 per year.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. Compensation & 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 Other Benefits • 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 Additional Information Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes. An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to ___. Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
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