Post: Sr Clin Ops Quality Specialist-1407867
RESPONSIBILITIES
• As a monitor, undertake normal activities as described by the senior CRA job description with extensive training in risk management, escalation of issues and corrective actions. This role will be trained in data analysis in order to identify potential sites, investigators or areas of risk.
• Act in a mentoring capacity and collaborate with the CRA to schedule and conduct a quality assessment site visit, where requested by the Clinical Operations Quality Manager or designee. The role's mentoring process will not take the place of any internal Quintiles, or customer audits which will be conducted as required by QA for projects, or processes. May assist the Clinical Operations Quality Manager in providing guidance and support to the clinical monitoring and management team in development or completion of a Clinical Corrective Action Plan.
• Working together with assigned CRA(s) conduct activities, as outlined in preparatory meetings to evaluate the site's process and procedures from a macro prospective (inclusive of Quintiles and/or Sponsor SOPs if applicable).
• Document observations and make recommendations to the Clinical Operations Quality Manager or designee and appropriate clinical staff, at the conclusion of the visit.
• Provide feedback to Clinical Operations Quality Manager or designee on all aspects of compliance, SOP development and customer requirements and work closely with operational teams to review, escalate and manage the quality issues, assist in corrective action plans preparation and implementation. This includes providing assistance during audits and regulatory inspections and partnering with QA in case of suspicions of fraud or misconduct.
• Inform Clinical Operations Quality Manager or designee of significant quality issues as they arise, in accordance with appropriate operating procedures/work instructions, as well as patient safety, regulatory compliance and data integrity.
• Act as a trainer and mentor for Clinical Operations Quality Specialists.
• Perform any other reasonable tasks as required by the role and delegated by the Clinical Operations Quality Manager or designee.
• As a monitor, undertake normal activities as described by the senior CRA job description with extensive training in risk management, escalation of issues and corrective actions. This role will be trained in data analysis in order to identify potential sites, investigators or areas of risk.
• Act in a mentoring capacity and collaborate with the CRA to schedule and conduct a quality assessment site visit, where requested by the Clinical Operations Quality Manager or designee. The role's mentoring process will not take the place of any internal Quintiles, or customer audits which will be conducted as required by QA for projects, or processes. May assist the Clinical Operations Quality Manager in providing guidance and support to the clinical monitoring and management team in development or completion of a Clinical Corrective Action Plan.
• Working together with assigned CRA(s) conduct activities, as outlined in preparatory meetings to evaluate the site's process and procedures from a macro prospective (inclusive of Quintiles and/or Sponsor SOPs if applicable).
• Document observations and make recommendations to the Clinical Operations Quality Manager or designee and appropriate clinical staff, at the conclusion of the visit.
• Provide feedback to Clinical Operations Quality Manager or designee on all aspects of compliance, SOP development and customer requirements and work closely with operational teams to review, escalate and manage the quality issues, assist in corrective action plans preparation and implementation. This includes providing assistance during audits and regulatory inspections and partnering with QA in case of suspicions of fraud or misconduct.
• Inform Clinical Operations Quality Manager or designee of significant quality issues as they arise, in accordance with appropriate operating procedures/work instructions, as well as patient safety, regulatory compliance and data integrity.
• Act as a trainer and mentor for Clinical Operations Quality Specialists.
• Perform any other reasonable tasks as required by the role and delegated by the Clinical Operations Quality Manager or designee.
Candidate Profile:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Sound knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulation and quality performance initiatives and processes
• Knowledge of CRO or Pharmaceutical industry operations
• Knowledge of Quintiles corporate standards and SOPs
• Good organizational, interpersonal and communication skills
• Good judgement and decision-making skills
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Sound knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulation and quality performance initiatives and processes
• Knowledge of CRO or Pharmaceutical industry operations
• Knowledge of Quintiles corporate standards and SOPs
• Good organizational, interpersonal and communication skills
• Good judgement and decision-making skills
JOB DESCRIPTION
• Strong influencing and negotiation skills
• Strong computer skills including Microsoft Office and Clinical Management applications
• Excellent problem solving skills_
• Demonstrated ability to work in a matrix environment
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Strong influencing and negotiation skills
• Strong computer skills including Microsoft Office and Clinical Management applications
• Excellent problem solving skills_
• Demonstrated ability to work in a matrix environment
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in a healthcare or other scientific discipline and 5 years of on-site monitoring experience; or equivalent combination of education, training and experience.
• Prior Quintiles clinical monitoring experience is required.
• Bachelor's degree in a healthcare or other scientific discipline and 5 years of on-site monitoring experience; or equivalent combination of education, training and experience.
• Prior Quintiles clinical monitoring experience is required.
Additional Information:
Experience: 5 years
Location: India
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Experience: 5 years
Location: India
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
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