Senior Clinical Data ManagerPharming Group • Saint Paul, Illinois, United States
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Senior Clinical Data Manager
Pharming Group
- Saint Paul, Illinois, United States
- Saint Paul, Illinois, United States
Über
Our Vision Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.
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 in‑house data management expert within a near‑to‑fully outsourced clinical execution model. The Sr. CDM provides strategic oversight and hands‑on leadership of all data management activities across the development programs in the Pharming portfolio, building fit‑for‑purpose data capture systems, cleaning databases, and coordinating third‑party data transfers to facilitate trial reporting.
Responsibilities
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 cross‑functional alignment on data strategy.
Support the development of study‑specific database builds using study protocol and configuration specifications, including performance of 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., 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 treatment‑emergent flags, exposure metrics, and safety population definitions produced by CRO partners.
Lead TLF 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 rapid‑turnaround 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 Base salary range: $130,000 – $170,000 per year. Salary consideration includes candidate’s work experience, training, education, role scope, complexity, and market data.
Compensation & Benefits
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 should make a request via email to HR-US@pharming.com.
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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Sprachkenntnisse
- English
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