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.
Post : Clinical Operation Quality Specialist
RESPONSIBILITIES
• Adopt and implement the Global Quality Management Plan within the scope of the assignment with the support of a mentoring Quality Manager/Senior Quality Specialist; this will include:
o planning and executing the Quality Management activities;
o risk identification and assessment through data review and quality control processes either remote or on site;
o providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
o supporting the assigned business line management and staff to enhance effectiveness of Site Visits conducted by them.
• Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to operational teams within the assigned business line, including Clinical Research Associates, Line/Site Network Managers, Resource Managers and other key stakeholders on all aspects of GCP compliance.
• Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
• Inform Heads of Quality Management, Heads of the assigned business line and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct; as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of Qulaity Management and as required by the applicable SOPs.
• Act as the primary contact for Quality Assurance on clinical quality matters – on the level of the assignment -, attend meetings/teleconferences.
• Prepare periodic reports to Heads of Quality Management and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
• Upon agreement with the Head of Quality/Operational Management:
o Perform any other reasonable tasks as required by the role.
Core Clinical only
• May assume a customer (site or sponsor) facing role to the extent required by the assignment and applicable SOPs.
GFR only
• Assigned to sponsor, assume customer (site and sponsor) facing role to the extent required by the assignment and applicable SOPs.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
• Knowledge of National and International Regulations and Drug Development 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
• Good influencing and negotiation skills
• Strong computer skills including Microsoft Office and Clinical Trial Management System (CTMS) applications
• Demonstrated ability to work in a matrix environment
• Excellent problem solving skills
• Ability to travel within the region/country
• Ability to lead and motivate a clinical team
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers
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Candidate Profile
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 3 years’ experience in Clinical Monitoring including at least 2 years’ experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead preferably within Quintiles; or equivalent combination of education, training and experience.
• Fluent in English.
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
• Regular travel
Additional Information:
Experience: 3 years
Location: Mumbai, Chennai, Ludhiana
Education: Maharashtra-Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality Specialist
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