|Job Category||Professional Consulting|
|Position Type||Full Time|
|Application Deadline||December 31, 2021|
|Experience Required||5+ years|
Maxsys Staffing & Consulting is pleased to assist our client in hiring a Clinical Research Associate Manager (permanent) in Ottawa/Remote.
Work with Clinical Affairs leadership to foster growth, development of all Clinical Research Associates across company, serve as global clinical research training expert across clinical organization by onboarding, ongoing training, support, mentoring and performance management to develop the skill sets and knowledge necessary to conduct clinical research studies.
· Hold a leadership role, manage direct reports, conduct ongoing review of staff, project assignments ensuring support, meet Divisional Clinical Research goals for multiple projects.
· Interface with Clinical Project Teams, Research and Operational Managers.
· Design, develop, execute, maintain Clinical Affairs new hire training program. Develop or update related SOPs and documents.
· Evaluate, ensure consistency of training plans for CRAs.
· Hire, lead and develop CRA staff. Ensure quality deliverables, in accordance with SOP’s.
· Ensure compliance with Corporate/Divisional Policies & Procedures.
· Implement, maintain effectiveness of the Quality System. Identify issues related to clinical monitoring activities. Summarize findings, establish action plans for corrective actions.
· Review processes/documents identify/implement any improvements. .
· Remain current on developments in field of expertise including clinical & i-STAT product knowledge.
· Identify, adapt to shifting priorities, competing demands, understand, comply with EHS policies, procedures, guidelines.
Required Education and Experience:
· Knowledge of regulations/standards affecting IVDs (In Vitro Diagnostics) & Biologics.
· Minimum Bachelors Degree in a discipline appropriate to a Clinical Research, Scientific, Medical, Technical or related field.
· 8+ yrs experience as a CRA, direct Clinical Research experience
· Proven ability/experience training CRAs &sites on Clinical topics.
· Experience directly supporting and training for clinical research or similar experience in a medical/scientific area.
· Experience managing, training CRA professionals within a team and in cross-functional development settings.
· Ability to confidently speak in public, lead meetings & discussions.
· Certification from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
· Medical Device/Diagnostics Clinical experience, understanding a clinical laboratory, assay/instrument principles involving in vitro diagnostic product design/usage.
· Experience using i-STATE system, managing other clinical operations positions.
· Able to travel up to 10% of the time.
All interested applications MUST meet the above requirements. Only those who meet the above criteria will be contacted.
Please apply with an updated resume including your email address and telephone contact number, as soon as possible.
MaxSys Staffing & Consulting
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