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.
Ensures Data Management Plans are followed through the course of the studies
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 or establishes CDM timelines to synchronize deliverables with the overall study timelines
Proven ability to perform detailed hands-on work as well as high-level strategic task
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
Performs duties as assigned by CDM management/Head of Department.

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
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
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.

Benefits

medical, dental, vision insurance
401(k) match
PTO
paid holidays
annual performance incentive bonus
new hire equity package

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

data managementclinical trial processregulatory requirementsattention to detailorganizational skillsCRO managementdecision-makingcontinuous improvementdata accuracystudy document generation

Soft skills

superior organizational skillsindependent workteam collaborationcritical thinkingflexibilityadaptabilitypositive attitudeapproachabilitystrategic task managementfeedback provision

Certifications

Bachelor’s degree in Life SciencesMaster’s degree in Life SciencesBachelor’s degree in Computer SciencesMaster’s degree in Computer SciencesBachelor’s degree in MathematicsMaster’s degree in MathematicsGCP certificationICH certificationFDA compliance trainingclinical trial certification