Bachelor’s or professional allied health degree required;
• Must be proficient with applicable GCP/ICH, regulatory requirements, and industry data management standards
• Strong attention to detail, good organizational skills, ability to work independently
• 6-8 years minimum experience in clinical data management
• Must have experience with all clinical data review processes including query generation/ resolution, reconciliation, closeout procedures, and applicable documentation of data management processes
• Must have experience with EDC systems
• Oncology experience required
Posted On -
5/15/2013 8:46:32 AM
• Bachelor’s degree and 8-10 years related experience. A minimum of 5 years generalist experience that should include talent acquisition, employee relations, employee development, compensation, benefits administration, safety, payroll, communications, and legal compliance. Supervisory experience required. PHR or SPHR designation preferred.
• Ability to directly supervise employees and carry out supervisory responsibilities in accordance with the Company’s policies and applicable laws.
• Ability to interview, hire, train; assign and direct work; perform performance appraisals, reward and discipline employees; and address complaints and resolve problems.
• Must have strong interpersonal, analytical and communicative skills to effectively present ideas, suggestions and feedback.
Posted On -
5/15/2013 8:42:26 AM
•Bachelor-level degree in quality and/or biological sciences or related subjects is required; Graduate level degree preferred.
•Must have knowledge of FDA, EMEA and JP regulations as they pertain to building design, aseptic process requirements and development of antibody-based bio therapeutics.
•Experience working in a GMP environment is required; experience working in a biologics Pilot Plant facility is preferred.
•Position requires at least 5 years performing standard Quality Assurance functions (for example; SOP and protocol writing, batch record review, quality specifications development, batch release functions, training, auditing, etc.), with at least 3 years in a leadership or supervisory role.
•Experience with equipment and facility deviation, and change management is required
•Working knowledge of standard industry IT solutions (i.e. LIMS, SAP, Trackwise) is preferred.
•Problem-solving and decision-making skills, and the ability to prioritize and successfully manage complex and competing projects is required.
Posted On -
5/15/2013 8:37:03 AM