Clinical Project Manager # JN -072021-67485

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Industry: Business Analyst / Project Manager
Job Number:

Title                          : Clinical Project Manager

Location                   : Santa Clara, CA

Duration                  : 10 months contract

 

100% Remote for an ideal candidate

 

Primary Job Function

Oversee the development of Clinical Evaluations (Plans and Reports) for new and existing medical devices, utilizing skill set of scientific project management, content expertise, knowledge of research design/methodology, and medical writing/editing. Provides scientific expertise throughout the development and implementation of clinical evaluations and other risk management deliverables. Work significantly with cross-functional teams and independent medical experts to develop deliverables for the Clinical Affairs team. Interacts with regulatory agencies as needed and will use their scientific and medical knowledge to provide directives to staff independently as well as directed by your manager.

 

Core Job Responsibilities

  • Takes lead as scientific project manager, writing/editing scientific content of deliverables and managing their timelines and the contribution of cross functional input.
  • Writes Clinical Evaluation Plans and Clinical Evaluation Reports and other clinical deliverables ,
  • Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager. Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.;
  • Creates, manages, or participates in timelines of deliverables, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
  • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
  • Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
  • Participates in and supports audits.
  • May participate in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

 

Preferred Skills and Experience: 

  • Medical Device Experience
  • Strong Project Management Experience
  • Strong Medical Writing/Editing Experience
  • Scientific/research background (i.e., has understanding of research design, methodology, and statistics)
  • May consider less experience and hire at lower level

 Minimum Education

  • Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 8+years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience

Minimum Experience / Training Required

  • Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.

 


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