Associate Director Clinical Trial Services
vor 6 Stunden
**About Discovery Life Sciences**:
Discovery Life Sciences is a global market leader in biospecimen solutions and laboratory services, offering an extensive range of products and services to support drug discovery and development. With a network of laboratories and offices across the United States and internationally, we are committed to advancing scientific research and improving health care outcomes. We are dedicated to accelerating the discovery and development of new therapies and diagnostics by providing the highest quality biospecimens, in vitro preclinical products, and cell and gene therapy starting materials, coupled with specialty lab services.
**Position Qualifications (Education, Skills, Experience)**:
- University degree in biology or biochemistry, conferral of a doctorate graduation
- Several years professional experience in a laboratory for molecular biology, cellular biology or biochemistry
- Work experience in a regulated environment/quality management system (e.g. GCLP).
- Good basic computer knowledge
- Professional English skills
**Key Responsibilities**:
- Perform regular monitoring tasks as defined in the monitoring plan
- Coordination of routine lab work
- Coordination and control of inventory purchase & management. This includes negotiations with vendors and manufacturers for devices, reagents and lab equipment, review of purchase orders, supply chain management, supervision of service agreements and the validation of lab devices
- Consulting for other departments and customers in histopathology-related activities
- Review of request of proposals, project plans/SOWs/Analytical Plans and other related documents
- Ensuring that remedial actions are taken when test systems deviate from the laboratory's established performance specifications
- Providing orientation of testing personnel
- When batch controls are run, review all control slides each day of patient testing
- Signature of the proficiency testing attestation statement
- Review of all technical policies and procedures at least every two years
- Ensures that proficiency testing, alternative assessment, and QC procedures are sufficient for the extent of testing performed in the laboratory
- Computer programs must be checked for proper performance when first installed and after any changes or modifications; including assessment after implementation in the live (production) system. Any changes or modifications to the system must be recorded, and the General Supervisor must approve all changes, additions and deletions in programs, the test library, and major computer functions before they are released. This applies both to locally installed and remotely hosted software. Records must be retained for at least two years beyond the service life of the system
- Generation, maintenance and optimization of lab procedures
- Fulfill necessary quality requirements for clinical testing under GCP and current accreditations
- Monitoring of lab activities according to the monitoring plan and guidelines
- Support of audit activities / CAPA management
- Harmonization of lab activities / processes between Discovery Life Sciences Biomarker Services GmbH and global affiliates
We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success.
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