Sr Manager Clinical Data Management
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 Sr Manager of Clinical Data management will be accountable for overseeing the data management operation activities for up to 8 programs.
- 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 the Data Managers by monitoring their individual objectives and key results
- Evaluate training needs and may be asked to participate in the 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.
- 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 & skills
- BSc in life sciences
- Exceptional project management skills
- Excellent organisational and communication skills;
- ‘Can-do’ attitude and willingness to be flexible
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
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.