Data Management Project Lead job in United Kingdom

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

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

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

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.)

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Impactful work. Meaningful careers. Quality rewards.

At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential.
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Data Management Project Lead

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