Clinical Research Manager in Santa Rosa at Apple & Associates

Date Posted: 5/25/2018

Job Snapshot

  • Employee Type:
  • Location:
    Santa Rosa
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Clinical Research Manager

Our client, the World Leader in Medical Device Development and Manufacturing, has an opening for a Clinical Research Manager!  The Clinical Research Manager will be responsible for management of all clinical activities related to one or more clinical studies. This may include performing and/or overseeing the daily in-house operations associated with the studies. Independently handle various clinical study assignments. Manages clinical team assigned to these clinical studies to ensure studies are conducted to meet business objectives and stay on time, to budget and are completed with highest quality.

This role can be worked from the Santa Rosa location or can be a REMOTE location (remote location will increase travel to 40-70% on average)

Clinical Research Manager Responsibilities:

  • Manage clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Interprets and executes on policies and procedures appropriate to clinical programs under his/her management. Recommends modifications to policies and procedures to larger clinical organization as necessary..
  • Accomplishes results through experienced clinical research employees who exercise significant latitude and independence in their assignments
  • Provides ongoing training, direction and guidance on all clinical programs under their supervision.
  • Conduct quarterly performance reviews and continuous employee development.
  • Provide leadership and program representation with internal partners and external customers.
  • Supervise training of study personnel including internal staff and external study sites (e.g. Principal Investigators, Study Site Support Staff, etc.)
  • Functions as an advisor to the Clinical Department Leadership regarding study strategy, projects, individual tasks and overall study operations.
  • Ensures projects/programs are completed on schedule and within budget. Will drive highest quality program execution. Continually assess best practices and implement continuous improvement across studies as well as provide input to global department program execution.
  • Participate on key functional workgroups to drive clinical wide or cross-departmental initiatives.
  • Provide significant input and oversight to clinical program budgets.
  • Ensures appropriate resources are maintained to effectively conduct clinical programs.
  • Gives direction to staff on program priorities for various projects assigned to their area.
  • Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues.
  • Identifies opportunities to strengthen clinical program quality and efficiency by assessing resource needs and capacities to ensure business objectives are met.

Clinical Research Manager Requirements:
  • Bachelor’s degree
  • 8+ years’ experience managing clinical research studies. (Master’s degree will substitute for 1 year experience; Ph.D. will substitute for 2 years’ experience).
  • Experience managing clinical trials from start to finish.
  • Experience managing global clinical trials; industry sponsored
  • Experience providing work direction to staff and accomplishing study execution through others
  • Hands-on experience with writing protocols, study documentation, help with regulatory and compliance questions or approvals, the full study life cycle

Clinical Research Manager Desired/Preferred Qualifications:

Bachelor’s Degree in engineering, life sciences or related medical/scientific field.

  • Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field).
  • Previous personnel management
  • Experience managing cardiovascular medical device and/or pharmaceutical trials
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003, Good Clinical Practice(GCP)
  • Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals
  • Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness.
  • Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
  • Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
  • Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills
  • Willingness to accept challenging assignments and engage in relevant developmental activities
  • Proficient knowledge of medical terminology
  • Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
  • Demonstrated ability to clearly and effectively communicate verbally and in writing
  • High attention to detail and accuracy
  • Exceptional project management capabilities and proficient use of project management tools