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Celcuity · 1 day ago

Senior Manager, Clinical Data Management

United States

Full-time

Remote

Senior Level, Lead/Staff

$175K/yr - $192K/yr

10+ years exp

Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. The Senior Manager, Clinical Data Management will oversee the CDM process, ensuring quality and timelines for clinical data management deliverables while managing junior staff and contributing to departmental initiatives.

BiotechnologyHealth CareHealth DiagnosticsTherapeutics

Responsibilities

Responsible for timelines and quality of CDM deliverables for the assigned studies

Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc

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 process for outsourced activities

Directs activities of direct reports as applicable

Participates in department or cross-functional initiatives as appropriate

Represents CDM in study team meetings

Manages CDM timelines to coordinate and synchronize deliverables with the 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)

Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices)

Monitors the progress of all CDM activities for the project to ensure project timelines are met

Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal

Performs duties as assigned by CDM management/Head of Department

Qualification

Clinical Data ManagementCRO managementEDC systemsRegulatory knowledgeOncology experienceContinuous improvement mindsetOrganizational skillsCommunication skillsDecision-making skillsAdaptability

Required

Bachelor's, or master's degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field

Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry

Three (3) year of staff management desired

Demonstrated ability to pay attention to details and superior organizational skills

CRO management experience

In-depth knowledge of CDM principles, clinical trial process and regulatory requirements

Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting

Good working knowledge of ICH, FDA, and GCP regulations and guidelines

Proven ability to work both independently and in a team setting

Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug

Ability to work in a team or independently as required

Outstanding organizational skills with the ability to prioritize

Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment

Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization

Flexible and willing to learn; adapting to business and site needs in a dynamic environment

Maintain a positive, approachable and professional attitude