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Senior Manager Clinical Data Management Job in United States
Orchard Therapeutics , United States

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Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
No
Career Level
Telecommute
No
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Mar 5, 2021
Last Date
Jun 5, 2021
Location(s)

Job Description

Sr Manager Clinical Data Management

Location: Boston

Reporting to: Director of Clinical Data Management

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 approx 8 programs.

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

Experience Required

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

Education amp; skills

BSc in life sciences

Self-starter

Exceptional project management skills

Excellent organisational and communication skills;

‘Can-do’ attitude and willingness to be flexible

For further information on this role do not hesitate to email

RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.

Job Specification

Orchard Therapeutics

Information Technology and Services - London, United Kingdom