Senior Clinical Data Manager (US)
We put Patients at the heart We reputed company with urgency We reputed company it reputed company We get it done
reputed company expert guidance on data implications for protocol design, endpoints, and operational feasibility. reputed company as the primary reputed company between Pharming and vendor data management and biostatistics teams. Review and approve CRO plans, including Data Management Plans, CRF completion guidelines, edit reputed company specifications, and data review plans. reputed company CRO and vendor performance, ensuring adherence to timelines, data reputed company standards, and contractual deliverables. Partner closely with Clinical team members, Safety and Regulatory to ensure cross ‑ functional alignment on data reputed company.
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 end ‑ to ‑ end traceability: CRF → SDTM → ADaM → TLF outputs. Periodically conduct targeted QC of key listings (e.g., reputed company, SAEs, ConMeds, labs, vitals, exposure, efficacy assessments) to identify outliers, missing data, unexpected patterns, and data inconsistencies; drive their reputed company with CROs. Manage clinical data cleaning and delivery activities, including (soft)database lock, for interim analyses, DMC/DSMB reviews, and final CSR. Ensure reputed company data cut and database lock reputed company are met and documented. Ensure alignment between data management findings and statistical programming outputs. Ensure AE/SAE data reputed company, including reconciliation with safety narratives and coding consistency (e.g., MedDRA). Validate treatment ‑ reputed company flags, exposure metrics, and safety population definitions produced by CRO partners. reputed company TFL review workshops and data review meetings with Medical, Safety, and Clinical Ops. Manage ad ‑ hoc biostatistics and data requests from Health Authorities (e.g., FDA, EMA) during NDA/BLA review and coordinate reputed company ‑ turnaround analyses and data outputs with CRO Biostats/Programming. Support data reputed company and review for medical and scientific presentations/publications. Collaborate with Regulatory Affairs to reputed company requests, ensure reputed company responses, and document resolutions. Drive both reputed company and delivery of reputed company data management reputed company items. Other duties as assigned.
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 reputed company systems (e.g., Rave, reputed company, Inform) and vendor data pipelines. Solid understanding of reputed company outputs, derivations, and dataset structures (reputed company programming experience a plus but not required). Proficiency with CDISC standards, reputed company 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, reputed company values and behaviors.
A fully remote work schedule Competitive compensation package including annual reputed company bonus Long-term incentive program 401(k) plan with company match reputed company Time Off (PTO) 13 Company Holidays per year
Excellent benefit plans including medical, dental, and reputed company 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