Senior Manager, Clinical Data Management

ManagerManagerFull TimeRemoteSeniorTeam 51-200Company SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$175K - $192K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

• Report into the Executive Director, Clinical Data Management. • Focus on all aspects of the CDM process from project planning, development of project documentation, system set-up, UAT through database lock. • Responsible for timelines and quality of CDM deliverables for the assigned studies. • Contributes to technical infrastructure of CDM such as the 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 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.

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.

Benefits

  • Annual performance incentive bonus
  • New hire equity package
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) match
  • Paid time off
  • Paid holidays

Related Job Pages

More Manager Jobs

Manager1 day ago
Part TimeRemoteTeam 11-50H1B No Sponsor

Case Manager supporting clients in virtual Intensive Outpatient Program at Meridian Recovery

California
$20 - $23 / hour
Mission Healthcare logo

Home Health Quality Care Manager, RN

Mission Healthcare

We take care of people by delivering personalized home health, hospice & transitional care services.

Manager1 day ago
Full TimeRemoteTeam 1,001-5,000Since 2009

Home Health Quality Care Manager overseeing clinical patient services at Mission Healthcare

United States
$85K - $95K / year
Campus Compact logo

Manager, Narrative & Storytelling

Campus Compact

Educating citizens, building communities.

Manager1 day ago
Full TimeRemoteTeam 11-50Since 1985

Manager, Narrative & Storytelling at Campus Compact driving communication strategy

United States
$70K - $75K / year
Hairball logo

Project/Delivery Manager

Hairball

Hundreds of companies of all sizes partner with Hairball to automate, integrate, and transform their business.

Manager1 day ago
Full TimeRemoteTeam 11-50Since 2021

Project Manager at Hairball leading NetSuite integration projects remotely.

ERP
United States