Opening to Work as Clin Ops Quality Specialist in Quintiles

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.

Post: Clin Ops Quality Specialist-1417611

Job Description
Purpose 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 analyzing 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. Conduct routine monitoring activities for assigned project as required.

• 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.
• 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.

All responsibilities are essential job functions unless noted as nonessential (N).

Candidate Profile:
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
- 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

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Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in a health care or other scientific discipline or educational equivalent with 3 years of on-site monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
• 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
• Occasional travel

Additional Information:
Experience: 3 years
Location: India
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 25^th November 2014