Associate Director, Clinical Team Management at Syneos Health in Remote
Description Who We Are Synteract , a Syneos Health company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases. Position Overview The Associate Director, Clinical Team Management is responsible for the overall management and coordination of the clinical team management team and monitoring of daily activities to ensure the successful completion of clinical trials. S/he oversees the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH -GCP Guidelines and SOPs. Additionally, s/he supports overall management of the department in collaboration with Clinical Operations senior management Specific tasks would include:
Line manages Clinical Team Managers (CTMs) Interacts with applicable pharmaceutical, biotechnology clients and vendors to ensure that contractual obligations related to clinical activities are met. Acts in the role of, or provide support to, the primary clinical point of contact for Client representatives as well as team members to ensure the timely initiation and completion of clinical trials. Contributes to the management of the clinical budget and out of scope documentation throughout the duration of the project. Provides input to the Clinical Operations portion of proposals, budgets and contracts. Supports Business Development in preparing and defending requests for proposals. Contributes to the development of training programs to ensure opportunities for employee development and advancement. o Responsible for ensuring employee training plans are set up, followed and completed. Mentors and trains CO personnel in clinical study monitoring and management and the relevant applicable regulations, ICH-GCP Guidelines; ensures standards for monitoring and reporting are met. Responsible for completing employee appraisals, as required; communicates with superior and HR to review salary and recommend promotion (horizontal or vertical). Assists in resolution of CO personnel performance issues; including termination as necessary. o Assesses employees and provides on-going feedback and recommendations for development. Effectively manages workload of supervised staff, with continual assessment and adjustment as necessary. Qualifications Bachelor's degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience. 10
year's relevant experience, including a minimum of 2 years directly managing others effectively. Considerable depth of experience in clinical study management, monitoring, and in developing study-related documents. In-depth knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Line manages Clinical Team Managers (CTMs) Interacts with applicable pharmaceutical, biotechnology clients and vendors to ensure that contractual obligations related to clinical activities are met. Acts in the role of, or provide support to, the primary clinical point of contact for Client representatives as well as team members to ensure the timely initiation and completion of clinical trials. Contributes to the management of the clinical budget and out of scope documentation throughout the duration of the project. Provides input to the Clinical Operations portion of proposals, budgets and contracts. Supports Business Development in preparing and defending requests for proposals. Contributes to the development of training programs to ensure opportunities for employee development and advancement. o Responsible for ensuring employee training plans are set up, followed and completed. Mentors and trains CO personnel in clinical study monitoring and management and the relevant applicable regulations, ICH-GCP Guidelines; ensures standards for monitoring and reporting are met. Responsible for completing employee appraisals, as required; communicates with superior and HR to review salary and recommend promotion (horizontal or vertical). Assists in resolution of CO personnel performance issues; including termination as necessary. o Assesses employees and provides on-going feedback and recommendations for development. Effectively manages workload of supervised staff, with continual assessment and adjustment as necessary. Qualifications Bachelor's degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience. 10
year's relevant experience, including a minimum of 2 years directly managing others effectively. Considerable depth of experience in clinical study management, monitoring, and in developing study-related documents. In-depth knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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