Sr Clin Ops Quality Specialist-1510705
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Conduct on site risk assessment visits with CRAs to investigate risks associated with the conduct of clinical trials and the tasks performed on site in the normal course of business. Document the risk assessments by collecting, reporting and analysing data from the areas of concern pre-identified by the Clinical Operations Quality Manager or designee. May be assigned as a liaison to specific sponsors or therapeutic group for risk assessment visits. Assist in implementation and delivery of the agreed upon Global Quality Control plan which includes risk management, to assist Clinical Operations to deliver a better compliance with relevant
ICH, GCP, country regulations and guidelines. Act as a trainer and mentor for CRAs.
• Act in a mentoring capacity and collaborate with the CRA to schedule and conduct a quality assessment site visit when requested by Clinical Operations Quality Manager or designee. The role’s mentoring process will not take the place of internal Quintiles, or customer audits which will be conducted as required by QA for projects, or processes.
• Working together with assigned CRA (the Team) conduct activities, as outlined in preparatory meetings to evaluate the site’s process, procedures and training from a macro prospective (inclusive of Quintiles and/or Sponsor SOPs if applicable).
• Document observations and make recommendations to 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 the Clinical Operations Quality Manager or designee of any significant quality issues as they arise, in accordance with appropriate operating procedures/work instructions as well as patient safety, regulatory compliance and data integrity.
• Perform any other tasks as required by the role and delegated by the Clinical Operations Quality Manager or designee
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 judgment and decision-making skills
• 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 co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
Bachelor’s degree in a health care or other scientific discipline or educational equivalent with 4 to 5 years of on-site monitoring experience or 2-3 years of project management experience; or equivalent combination of education, training and experience. Previous experience of working in Quality functions is also acceptable.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Travelling to sites/offices for review
Primary Location: India
Organization: IND02 – India – CDS/Product Devel
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