PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post : Associate Clinical Manager
Job Purpose:
Oversees daily line management responsibilities of assigned team. Serves as positive leadership and professional role model for respective staff, which may be inclusive of CRAs, PAs, RSMs and other clinical focused staff. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus on line and performance management of team members. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.
Job Description:
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Manages staff, providing coaching, mentorship and work direction
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Conducts regular performance appraisals and career discussions with staff.
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Facilitates employee career development. Interviews, recruits and selects staff
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Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company
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Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
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Ensures timeliness and accuracy of timesheets and expense reports
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Supports allocation activities per the local resourcing process.
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Supports activities of project managers and clinical team managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables
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Delivers training on Working Practice Documents (WPDs) and Standard
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Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations.
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Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate
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Alerts management to quality issues, requests QA audits as appropriate, and facilitates client and internal quality assurance audits as required.
Candidate Profile
Bachelor's Degree in a life science related field or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. In some cases, an equivalent combination of education, professional training and experience that provides the required knowledge, skills and abilities may be considered. Suitable clinical research experience (comparable to 1 - 5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region. Valid Driver's License and Passport.
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Knowledge, Skills and Abilities:
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Demonstrated effective mentoring/leadership/supervisory ability
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Excellent clinical trials monitoring skills; Remote and on-site
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Demonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
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Ability to evaluate medical research data
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Effective organizational and negotiation skills
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Strong attention to detail
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Effective written and oral communication skills
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Good knowledge of English language and grammar
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Competent use of computer to include data entry, archival and retrieval
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Ability to travel as needed
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Excellent team player with team building skills
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Excellent interpersonal and conflict resolution skills
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Ability to utilize problem-solving techniques applicable to constantly changing environment
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Proficient knowledge of medical/therapeutic areas and medical terminology
Physical Requirements:
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Frequently vertical and /or stationary for 6-8 hours per day.
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Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
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Frequent mobility required.
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Frequent bending and twisting of upper body and neck.
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Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
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Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
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Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
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Frequently interacts with others, relates sensitive information to diverse groups.
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Ability to apply basic principles to solve conceptual issues.
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Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
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Regular and consistent attendance.
Additional Information:
Exp: 1 - 5 years
Location: Karnataka-Bengaluru
Education: Bachelor's Degree in a life science
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Manager
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