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Company

myGwork - LGBTQ+ Business Community · 2 days ago

Project Data Manager

United States

Full-time

Remote

Mid Level

3+ years exp

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Responsibilities

Ensuring clinical projects are executed according to set timelines with quality and consistency

Leading DM activities for a given product or multiple products

Ensuring that DM procedures and processes are adhered to by FSP staff through oversight of quality, cycle times, metrics and use of the Issue CAPA process

Co-ordination and mentoring of lead data managers within assigned projects

Training and mentoring of DM TA staff on processes, projects and programs

Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM

Participate in and/or lead DM and cross functional working groups

Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education

Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors

Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics

Promote and be an advocate of DM internally and externally

Represent DM at project team meetings i.e., GCST

Project level coordination of and day to day oversight of DM tasks including:

Co-ordination of lead DM’s within the project

Review of all DM documents within a project area to ensure a consistent approach

Overview of project timelines and metrics to ensure databases are delivered to set timelines

Approve database locks and unlocks

Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards

Provide DM product level input to developing and managing resource plans and budgets for DM

Ensure that quality control checks are occurring such that quality databases are delivered

Develop and co-ordinate project level training for data management staff

Review and approve study specific training

Manage vendor deliverables and relationship at the project level

Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.

Review of all study level non DM documents for awareness and project level consistency

Lead electronic submission activities

Assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level

Qualification

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Data ManagementClinical ExperienceProject ManagementOversight of VendorsProcess DevelopmentLife Science DegreeComputer Science DegreeBusiness Administration DegreeCRO ExperienceQuality Assurance

Required

Doctorate degree OR

Master’s degree & 3 years of clinical experience OR

Bachelor’s degree & 5 years of clinical experience OR

Associate’s degree & 10 years of clinical experience OR

High school diploma / GED & 12 years of clinical experience

Preferred

Bachelors degree or equivalent in life science, computer science, business administration or related discipline

6+ years work experience in data management in the Pharmaceutical or Biotech arena

3+ years project management and planning experience

Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others