Like & Share this Job to inform others: AD, Clin Ops Quality Mgmt Quintiles Transnational - Bangalore, Karnataka || HD 6 ift.tt/1t2Fw8Z AD, Clin Ops Quality Mgmt Quintiles Transnational - Bangalore, Karnataka Description RESPONSIBILITIES · Be a permanent member in the Clinical Operations Quality Management global forum representing Global SRS function. · Direct the hiring and selection process for staff by conducting candidate review through participation in the interviewing process, if required. Evaluate current methods and develops office/region based tools for on-boarding training for new staff in conjunction with Human Resources and Global Talent training programs and monitor quality of SRS work in conjunction with SRS Line Managers. · Contribute to the development of a Global Quality Control Plan and Risk Management Program specifically related to SRS services. This will include the improvement/refinement in the current processes, methodology and tools and any corrective action required on the global level. · Managing the resourcing, provide direct oversight, driving consistency of processes across global SRS Team in conjunction with SRS Line Managers. Contribute to SVR related guidance documents · Lead/Facilitate regularly scheduled SRS Leads team meetings, serve as mentor and liaison to clinical operation management and other functional areas regarding SRS related activities (e.g. TDU, PCC, etc.) · Manage staff in accordance with organizations policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. · Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations · Ensure adequate communication with the Heads of Clinical Operations to get them engaged in the deployment of the SRS strategy. Act as the conduit between the local offices, attending ad hoc meetings/teleconferences as needed to exchange performance related data and information on quality issues and initiatives. · Provide advice and support to Clinical Site Monitoring, including Clinical Project Managers, Line Managers, Learning and Development and Quality Assurance on all aspects of compliance, SOP development and customer requirements and to work closely together with operational teams to manage (e.g. review, escalate) quality issues, prepare corrective action plans, to follow these through until full resolution and provide adequate documentation within an appropriate time frame. This includes providing assistance during audits and regulatory inspections and partnering with Quality Assurance in case of suspicion of fraud or misconduct. · Obtain and provide regular feedback to employees from key stakeholders to assist in personal and professional development. May attend project team meeting in order to support development needs. Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps. · Perform any other appropriate tasks as required by the role. Qualifications vREQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulations and quality performance initiatives and processes · Knowledge of National and International Regulations and Drug Development process · 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 · Demonstrated leadership and line management 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 lead and motivate a study team also required. · Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelors degree in life sciences or equivalent nursing qualification with a 6-8 years experience in Clinical Monitoring with 2-4 years experience in a role equivalent to CTL; 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 · Occasional travel APPLY HERE
Posted on: Tue, 16 Sep 2014 04:35:18 +0000
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