Project Manager

Full Time
Posted 4 months ago

Job Summary:

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.

Responsibilities:

  • 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.

Education/Abilities Requirements:QualificationsEEe 

  • 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.

 

 

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