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Senior Manager, Clinical Data Management

1 month, 1 week ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
GCP
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 10

Description

  • Own timelines and quality of clinical data management deliverables for assigned studies.
  • Contribute to clinical data management infrastructure, including SOP development and process improvements.
  • Provide feedback and task assignments to support department and company objectives.
  • Support budget and resource planning across assigned projects.
  • Participate in CRO and vendor selection for outsourced activities.
  • Direct activities of direct reports, as applicable.
  • Represent clinical data management in study team meetings.
  • Manage CDM timelines to align deliverables with overall study schedules.
  • Generate, review, and approve study documents such as protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, and coding conventions.
  • Oversee CRO and service providers, including review of vendor SOPs and invoices.
  • Monitor CDM activities to ensure project timelines are met.
  • Ensure accuracy and completeness of clinical data collected during clinical trials.
  • Participate in department and cross-functional initiatives as needed.

Requirements

  • Bachelor’s degree required; master’s degree preferred, in Life Sciences, Computer Sciences, Mathematics, or a health-related field.
  • Minimum 10 years of clinical data management experience in the pharmaceutical or biotechnology industry.
  • 3 years of staff management experience desired.
  • CRO management experience required.
  • In-depth knowledge of CDM principles, clinical trial processes, and regulatory requirements.
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Experience with web-based Electronic Data Capture systems, preferably Medidata Rave.
  • Experience with clinical data management systems and industry thesauri such as MedDRA and WHO Drug.
  • Prior oncology or hematology experience highly desirable.
  • Excellent verbal, written, and interpersonal communication skills, with the ability to collaborate effectively in a remote setting.
  • Strong attention to detail and superior organizational skills.
  • Ability to work independently and in a team setting.
  • Strong prioritization, critical thinking, and sound decision-making skills in a fast-paced environment.
  • Continuous improvement mindset with willingness to adapt and learn in a dynamic environment.
  • Positive, approachable, and professional attitude.

Benefits

  • Base salary range of $175,000-$192,000 DOE.
  • Eligible for an annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • PTO.
  • Paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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