The Project Manager ensures client deliverables are met on-time, within scope, and within established quality standards. This position regularly interacts with clients for current studies and potential future studies awarded.
- Responsible for client interaction and the conduct of studies.
- Responsible for data interpretation, analysis, and reporting of results for bioanalytical method development and validation.
- Responsible for the management of preclinical and clinical sample analysis using bioanalytical methods.
- Maintains and applies experience and knowledge of ligand-binding assays (e.g. ELISA / MSD) applicable to Pharmacokinetic, Biomarker and ADA studies to support existing and new client studies.
- Integrates bioanalytical contract research organization (CRO) business objectives in daily activities.
- Maintains knowledge and applies regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation and sample analysis.
- May mentor, train, or supervise new or less experienced team members.
- Participates in or contributes to business initiatives, such as process improvement, quality, culture, etc.
- Adherence to laboratory health and safety procedures.
- Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines.
- B.S. / B.A. degree in Biology or related field and a minimum of 10 years of relevant experience in the CRO industry; or advanced degree in Biology or related field and at least 5 years of relevant experience in the CRO industry.
- Knowledge of GLP regulations and regulatory guidelines.
- Excellent communication skills, both oral and written.
- Strong leadership and organizational skills.
- Excellent organizational skills.
- Proficient in the use of basic computer applications such as MS Word and Excel.
- Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.
- Proficient in time management and resource planning.
- Ability to effectively interact at all levels of the organization in addition to with clients and regulatory personnel.
- Ability to make decisions and complete assignments with minimal guidance.
- Ability to establish work priorities and manage shifting priorities.