Ref #: 25267

Employment type: Permanent - Full-Time

Location: United States

Posted: 08-Jan-2021

Description

DOCS is currently seeking an experienced Senior Data Management, Operations Lead professional for a remote based position. This is an exciting opportunity to work directly with a pharma client! We have multiple positions open that we are looking to fill with qualified candidates.

POSITION SUMMARY
• Executes Data Management (DM) activities per set timelines with quality and consistency for a given product or multiple products

JOB FUNCTIONS/RESPONSIBILITIES

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

Key Activities:
• 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:
o Co-ordination of lead DM’s within the project
o Review of all DM documents within a project area to ensure a consistent approach
o Overview of project timelines and metrics to ensure databases are delivered to set timelines
o Approve database locks and unlocks
o 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


SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
Knowledge
• Good Clinical Practice
• Drug development and clinical trials processes
• Data management processes
• Clinical trial databases and applications
• Systems development lifecycle
• Project planning and management
• Medical / life sciences in several therapeutic areas
• Quality management
• Vendor oversight
• Regulatory filings and inspections

Key competencies
• Teamwork
• Attention to detail
• Written and oral communication
• Problem solving
• Initiative
• Relationship building
• Project management
• Leadership skills
• Strategic thinking

SECTION 4: EDUCATION REQUIREMENTS

Basic qualifications
• 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 Qualifications
• 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.)

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.