Essential Functions
- Responsible for staff management in accordance with the organization's policies and applicable laws
- Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees
- Communicate and provide support/guidance to appropriate groups/staff as required to ensure established, revised and/or new processes are followed to ensure quality on-time/zero defect standards
- Plan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and are compliant with regulatory and internal procedure requirements.
- Attend and participate in study specific meetings related to study set up, timeline production and management, and study status
- May be required to carry out study tasks, including but not limited to, complete QC review of source data and raw data for studies, performing accurate data entry, attending internal study initiation meetings to determine QC criteria and timelines for studies
- Write QC and DE SOPs and Procedure guides and participate in SOP and Procedure Guide Reviews
- Create and track metrics associated with QC and DE responsibilities
- Present the QC processes to sponsors and auditors
- Lead Process Improvement initiatives to improve the quality of the source data
- Participate in regulatory inspections, audits and meet with Sponsors as required
- Monitor process efficiency and implement process improvement as needed, including data flow and identification of error trends and resolutions.
- Lead and/or participate in problem solving for the data collection, quality control and data entry processes.
Knowledge/Skills/Education/Licenses
- Bachelor’s degree in a related field is required.
- 1-2 years of supervisory or trainer/leader experience required.
- Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
- Ability to adjust hours to meet workload priorities
- Strong process improvement skills and change management experience
- Critical thinking skills
- Clinical data experience preferred
- **Equivalent education and experience will be consider
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Skills Required
- Bachelor's degree in a related field
- 1-2 years of supervisory or trainer/leader experience
- Knowledge of Good Clinical Data Management Practices, medical terminology, GCP, ICH Guidelines, and 21 CFR Part 11
- Ability to adjust hours to meet workload priorities
- Strong process improvement skills and change management experience
- Critical thinking skills
- Clinical data experience
- Equivalent education and experience
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
