Senior Manager, Clinical Data Management

ManagerManagerFull TimeRemoteTeam 51-200H1B No SponsorCompany Site LinkedIn

Location

Minnesota

Posted

64 days ago

Salary

$175K - $192K / year

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

• 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 • 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.

Job Requirements

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
Prior oncology/hematology experience highly desirable
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.