Ref #: 37818
Employment type: Permanent - Full-Time
Location: Clinical Operation Manager
Posted: 23-May-2022
Description
POSITION SUMMARY
• The role of the Line Manager is to line manage CRAs and/or CTAs effectively, ensuring high performance, quality and continuous development. Including interviewing, evaluating and selecting CTAs and CRAs
• To assist the sponsor in performing oversight in fulfilling its site management activities and obligations in relation to clinical studies as the primary sponsor of those studies.
• Create a culture of process improvement with a focus on streamlining processes adding value to our business and meeting client's needs
• Travel (approximately 50%) domestic and international
• In addition to work according to and comply with relevant ICON/ISS procedures and processes
Line Management Activities:
• Act as point of contact for client CTOM
• Manage key activities as needed to cover CRA/CTA absence
• Perform CRA accompanied visits within 3 months of CRA onboarding and routinely thereafter according to the Quality Oversight Plan
• Conduct activities detailed in the Quality Oversight Plan
• Interact with strategic partners (KOLs, Investigators and Site Staff) as necessary for execution of clinical trials and reinforcement of sponsor’s brand
• Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies, regulations and guidelines, including spot check review of reports and spot co-monitoring with CRAs
• Support FSP staff to achieve delivery of study objectives
• Supports CRAs with resolution of significant site issues and development of recruitment strategies
• Ensures that CRAs and CTAs are qualified and trained, both in clinical studies execution and in Sponsor policies and procedures, to provide data that meets quality requirements
• Provide leadership in the continuous improvement in CRA and CTA performance and monitoring processes
• Support staff with action plan development and resolution of findings from Clinical Quality Assurance audits
• Conduct resource planning and metrics review with Sponsor site management
• Conduct staff regular performance assessments and personal/career discussions with direct reports
• Responsible for providing regular updates to Senior Management and adhering to metrics
• Review and approve itineraries, expense reports, and visit reports for assigned staff
• Supervise IRB/IEC and Regulatory Authority Submission process if applicable
• Supervise administrative processes including document preparation, filing and archiving according to GCP and SOPs
• Supervise CRS related study start up process locally
• Supervise translation process
• Supervise eTMF process
Knowledge:
• Clinical trial processes and operations
• ICH/GCP Guidelines plus local codes of practice as applicable
Experience:
• For CRA LM: experience as CRA with LM potential as determined by hiring manager, CRA manager, project manager or equivalent job role
• For CTA LM: as above or experience as CTA with LM potential as determined by hiring manager
Competencies:
• Attention to detail
• Organizational skills
• Relationship management & influencing skills
• Time management & prioritization
• Training skills
• Flexibility
• Written and oral communication skills
• Language skills: English
• Good working knowledge of common software packages
• Presentation skills
• Problem solver
• Team work
Basic qualifications (meet 100%):
• BA/BS/BSc or qualified nurse (RN)
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
Preferred qualifications:
• BA/BS/BSc in the life sciences or RN
• The role of the Line Manager is to line manage CRAs and/or CTAs effectively, ensuring high performance, quality and continuous development. Including interviewing, evaluating and selecting CTAs and CRAs
• To assist the sponsor in performing oversight in fulfilling its site management activities and obligations in relation to clinical studies as the primary sponsor of those studies.
• Create a culture of process improvement with a focus on streamlining processes adding value to our business and meeting client's needs
• Travel (approximately 50%) domestic and international
• In addition to work according to and comply with relevant ICON/ISS procedures and processes
Line Management Activities:
• Act as point of contact for client CTOM
• Manage key activities as needed to cover CRA/CTA absence
• Perform CRA accompanied visits within 3 months of CRA onboarding and routinely thereafter according to the Quality Oversight Plan
• Conduct activities detailed in the Quality Oversight Plan
• Interact with strategic partners (KOLs, Investigators and Site Staff) as necessary for execution of clinical trials and reinforcement of sponsor’s brand
• Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies, regulations and guidelines, including spot check review of reports and spot co-monitoring with CRAs
• Support FSP staff to achieve delivery of study objectives
• Supports CRAs with resolution of significant site issues and development of recruitment strategies
• Ensures that CRAs and CTAs are qualified and trained, both in clinical studies execution and in Sponsor policies and procedures, to provide data that meets quality requirements
• Provide leadership in the continuous improvement in CRA and CTA performance and monitoring processes
• Support staff with action plan development and resolution of findings from Clinical Quality Assurance audits
• Conduct resource planning and metrics review with Sponsor site management
• Conduct staff regular performance assessments and personal/career discussions with direct reports
• Responsible for providing regular updates to Senior Management and adhering to metrics
• Review and approve itineraries, expense reports, and visit reports for assigned staff
• Supervise IRB/IEC and Regulatory Authority Submission process if applicable
• Supervise administrative processes including document preparation, filing and archiving according to GCP and SOPs
• Supervise CRS related study start up process locally
• Supervise translation process
• Supervise eTMF process
Knowledge:
• Clinical trial processes and operations
• ICH/GCP Guidelines plus local codes of practice as applicable
Experience:
• For CRA LM: experience as CRA with LM potential as determined by hiring manager, CRA manager, project manager or equivalent job role
• For CTA LM: as above or experience as CTA with LM potential as determined by hiring manager
Competencies:
• Attention to detail
• Organizational skills
• Relationship management & influencing skills
• Time management & prioritization
• Training skills
• Flexibility
• Written and oral communication skills
• Language skills: English
• Good working knowledge of common software packages
• Presentation skills
• Problem solver
• Team work
Basic qualifications (meet 100%):
• BA/BS/BSc or qualified nurse (RN)
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
Preferred qualifications:
• BA/BS/BSc in the life sciences or RN