Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services
Post : Manager, Site and Resource
PURPOSE
Lead and motivate a team of CRA staff within a designated office, country or region in order to achieve patient recruitment
targets to high quality standards, at sites. Ensure that the right resources are assigned to projects at the right time and that
staff gain the necessary skills to perform their respective job responsibilities to high professional standards. Drive and manage
Quintiles key strategic site relationships to build capability, drive productivity and robust quality management. Achieve
customer and investigator satisfaction in line with current strategies.
RESPONSIBILITIES
- Formulate strategies and action plans to maximize delivery of a high quality team/department monitoring service, ensuring
- achievement of individual/team/department targets, aligning with company strategies.
- Ensure sufficient level and profile of resource is recruited for each project. Maintain systems compliance and oversight for
- effective project delivery. Collaborate with the Clinical Lead/Project Lead to ensure that resource needs and site
- requirements are met.
- Drive and manage Quintiles key strategic site relationships in order to build capability, drive productivity and robust quality
- management in line with site strategy. Be an advocate for these sites within Quintiles.
- Manage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is
- achieved and project targets are met. Be an advocate for individual career development.
- Conduct Accompanied Site Visits (ASV’s) to develop CRA’s skills (e.g. patient recruitment). Support CRA’s on solving
- project specific issues across site portfolio.
- Identify quality risks and issues and suggest appropriate corrective action plans to senior management to prevent or
- correct deficiencies in performance of employees.
- Share Quintiles and customer key business drivers with all CRA staff. Drive decision making in line with these.
- Attend customer meetings, maintain interactions with any local sponsor affiliates.
- Maximize profitability by ensuring project objectives and customer requirements are achieved.
- Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide
- oversight for the execution of the training plan and mentored training experiences.
- Ensure timely and accurate reporting of required information on company systems.
- Support continuous improvement of monitoring processes to deliver quality, consistency and efficiency in delivery.
- Participate in the selection process for new staff by conducting candidate review and participating in the interviewing
- process. Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and
- Development training programs.
- Project a professional impression of the Company and act in accordance with the relevant Pharmaceutical Industry’s
- code of Practice
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning,
- assigning, and directing work; gathering feedback for appraising performance, guiding professional development;
- rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on
- human resources matters in consultation with Human Resources and other relevant departments.
- Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Broad understanding of the health and research environment, patient pathways through health systems and operational
- processes at research sites.
- Advanced knowledge and ability to apply GCP/ICH/applicable guidelines, solid understanding of new methodologies in
- research e.g. remote monitoring
- Excellent/Proven management and communication skills (written and verbal), ability to present to senior management.
- Ability to translate company strategy into motivational local practices
- Ability to coach/mentor and develop staff
- Ability to lead, collaborate and build effective relationships (including cross-functionally) with co-workers, managers, sites and customers
- Ability to plan and meet project objectives/conflicting priorities
- Strong project management and change management skills
- Excellent organizational and problem solving skills
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MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree, preferred in Healthcare or other scientific discipline and 7 years of clinical trials experience including 3 years’ experience in a leadership capacity, a broad understanding of general management practices desirable (e.g. The Oz Principle, The 4 Disciplines of Execution); or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
Extensive travel to sites (60-80% of time) with CRAs or to manage strategic site relationships, within a defined geographical location
Flexibility regarding working hours and geographical coverage.
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.
Frequent domestic travel.
Full driving license.
Connect to great opportunity
Additional Information:
Experience: 7 years
Location: Maharashtra-Thane
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Site and Resource
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