Senior Manager Clinical Data Management

Location
London, United Kingdom
Posted
Apr 21, 2021
Ref
3B81F7DA61
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Location: London

Reporting to: Director, Clinical Data Management

Job Summary

Reporting to the Director of Clinical Data Management, the Senior Manager, Clinical Data Management is a leadership role within the Clinical Operations and Data Management Department accountable and responsible for managing end-to-end delivery of data management services, collaborating with internal and external customers and ensuring staff deliver high quality, timely service and meet all regulatory requirements and guidelines.

The Senior Manager of Clinical Data manager will also be accountable for overseeing the data management operation activities for multiple programs.

Key Elements and Responsibilities
  • Accountable and responsible for meeting data management operational responsibilities and targets whilst adhering to ICH GCP
  • Ensuring operational efficiency and excellence by overseeing and/or assisting in the creation and documentation of new or revised department procedures.
  • Partner with internal and external stakeholders to optimize Data Management technology, processes and standards.
  • Participate in the evaluation and selection of data system vendors to enhance Data Management processes, e.g. EDC, IRT, ePRO.
  • Contribute to the financial success of the department and company by effectively managing financial aspects of assigned programs, including but not limited to Work Orders, Change Orders, study forecasting and budgeting.
  • Identify and quantify resource requirements for ongoing and future projects; Interview, hire, onboard and train new staff as appropriate
  • Supervise, mentor, provide leadership and oversee development of direct reports by setting individual objectives and key results to support department and company strategies and objectives
  • Evaluate training needs and conduct performance reviews for assigned staff
  • Set priorities and oversee activities for assigned staff.
  • Ensure Data Management deliverables for projects assigned meet/exceed project/study team expectations regarding quality, time, and cost.
  • Serve as the subject matter expert on data collection strategy and handling of study data for assigned programs and effectively liaise with programming to ensure clinical databases are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission.
  • Proactively identify data management project issues, manage risks and alert Department Management with a view to remedial action.
  • Interact/liaise with other departments to ensure a high level of client satisfaction through successful issue resolution and execution of projects.

Requirements

Required Knowledge
  • Applicants should have a minimum of 10 years of relevant experience within the pharmaceutical/CRO environment
  • Demonstrated experience leading data management teams is required.
  • Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
  • Understanding of regulatory environment, GCP/ICH

Skills and Abilities
  • Self-starter
  • Exceptional project management skills
  • Excellent organisational and communication skills;
  • 'Can-do' attitude and willingness to be flexible

Education
  • BSc in life sciences


Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.