Senior Manager, Clinical Data Management
Celcuity
9 hours ago
Remote friendly (United States)
United States
Operations
Responsibilities
Department Level:
- Responsible for timelines and quality of CDM deliverables for assigned studies.
- Contributes to CDM technical infrastructure (e.g., development of SOPs, departmental process improvement).
- Provides feedback and task assignment to meet department and company objectives.
- Supports budget and resource planning across assigned projects as required.
- Participates in CRO/vendor selection for outsourced activities.
- Directs activities of direct reports as applicable.
- Participates in department or cross-functional initiatives as appropriate.
DM/Study Tasks:
- Represents CDM in study team meetings.
- Manages CDM timelines to synchronize deliverables with overall study timelines.
- Generates and/or reviews/approves study documents (e.g., study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions).
- Provides oversight of CDM CRO/service providers (e.g., reviewing vendor SOPs, invoices).
- Monitors progress of all CDM activities for the project to ensure timelines are met.
- Ensures accuracy and completeness of clinical data collected during a clinical trial; works independently toward assigned goals.
- Performs duties as assigned by CDM management/Head of Department.
Qualifications
- Bachelor’s degree or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or a health-related field.
- Minimum 10 years of DM experience in the pharmaceutical or biotechnology industry.
- 3 years of staff management desired.
- CRO management experience.
- In-depth knowledge of CDM principles, clinical trial process, and regulatory requirements.
- Working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Excellent verbal/written interpersonal skills; able to collaborate with cross-functional teams in a remote setting.
- Experience with web-based EDC (preferably Medidata Rave), clinical data management systems, and industry thesauri (e.g., MedDRA, WHO Drug).
- Prior oncology/hematology experience highly desirable.
- Demonstrated attention to detail, strong organizational and prioritization skills.
- Proven ability to work independently and in a team setting; independent, sound decision-making and critical thinking.
- Continuous improvement mindset; flexible and willing to learn; maintain a positive, approachable, professional attitude.
Department Level:
- Responsible for timelines and quality of CDM deliverables for assigned studies.
- Contributes to CDM technical infrastructure (e.g., development of SOPs, departmental process improvement).
- Provides feedback and task assignment to meet department and company objectives.
- Supports budget and resource planning across assigned projects as required.
- Participates in CRO/vendor selection for outsourced activities.
- Directs activities of direct reports as applicable.
- Participates in department or cross-functional initiatives as appropriate.
DM/Study Tasks:
- Represents CDM in study team meetings.
- Manages CDM timelines to synchronize deliverables with overall study timelines.
- Generates and/or reviews/approves study documents (e.g., study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions).
- Provides oversight of CDM CRO/service providers (e.g., reviewing vendor SOPs, invoices).
- Monitors progress of all CDM activities for the project to ensure timelines are met.
- Ensures accuracy and completeness of clinical data collected during a clinical trial; works independently toward assigned goals.
- Performs duties as assigned by CDM management/Head of Department.
Qualifications
- Bachelor’s degree or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or a health-related field.
- Minimum 10 years of DM experience in the pharmaceutical or biotechnology industry.
- 3 years of staff management desired.
- CRO management experience.
- In-depth knowledge of CDM principles, clinical trial process, and regulatory requirements.
- Working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Excellent verbal/written interpersonal skills; able to collaborate with cross-functional teams in a remote setting.
- Experience with web-based EDC (preferably Medidata Rave), clinical data management systems, and industry thesauri (e.g., MedDRA, WHO Drug).
- Prior oncology/hematology experience highly desirable.
- Demonstrated attention to detail, strong organizational and prioritization skills.
- Proven ability to work independently and in a team setting; independent, sound decision-making and critical thinking.
- Continuous improvement mindset; flexible and willing to learn; maintain a positive, approachable, professional attitude.