https://quintiles.taleo.net/careersection/10260/jobdetail.ftl?job=1407867&lang=en
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
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.
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
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
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.
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
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