Study Manager (CTM), Client Dedicated - Oncology/Vaccines

Company: PPD Inc.
Location: Wilmington
Posted on: June 25, 2022

Job Description:

Study Manager __________________________________________________________________ Position Purpose: The Study Manager (SM) has responsibility for all study management aspects of assigned studies of limited complexity (e.g. single country, small number of countries) or manage a unique part of a larger study (e.g. recruitment and retention). The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release The SM provides quality oversight to the Clinical Research Organization (CRO) and of the CRO deliverables related to study execution. The Study Manager leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports. The Study Manager will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans. The Study Manager is a core member of the Study Team and will represent the CRO on matters of study execution. The Study Manager works with functional lines and directly with CRO line functions to resolve or triage site level issues. Organizational Relationships: * Reports to the FSP Manager.
* Responsible for liaising with members of the project team to include but not limited to: Clinical Study Team Lead (CSTL), SCC, Lead Data Manager (LDM), Lead CPW, Clinician, C&O, U.S. region and Pfizer Country Office (PCO) CSTLs.
* Will also liaise with Clinical Study Team Lead (CSTL), Asset Lead or Clin Ops Study Team Lead for technical system and process expertise and TA operational knowledge. Primary Duties: Operational Study Management for 1 or more studies of limited complexity (e.g. Pfizer Clinical Research Unit, single country, small number of 3rd party vendors) or manage a unique part of a larger study (e.g. recruitment and retention, 3rd party vendors) * Accountable for the development of realistic detailed study startup and monitoring plans
* Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
* Leads study risk planning process in context of site and subject
* Coordinates study/protocol training & supports investigator meetings
* Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
* Accountable for the delivery of the study or subset of agreed study activities against approved plans
* Leads inspection readiness activities related to study management and site readiness
* May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
* May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.) Study Management Oversight: * Approves the Study Startup, Study Monitoring & protocol recruitment plans
* Approves & oversees drug supply management - manages flow of drug supply to the sites & set up Interactive Voice Randomization System with Supply Chain Lead
* Reviews consolidated Pre-trail Assessment reports, feasibility outputs, etc. * May support study level submission readiness Study Team Interface: * Leads and oversees some or all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO to determine Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
* Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery * Shares and escalates plan deviations to Clinical Study Team Lead (and study team)
* May provide ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
* May provides operational input into protocol design Subject Matter Expertise: * The Study Manager will be the technical expert for study management systems and processes The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
* The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
* The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
* or project-specific audits and inspections, the Study Manager can serve as a resource to the study team to facilitate the audit/inspection. #LI-LM3 #LI-Remote Education and Experience: * Bachelor's degree or equivalent and relevant formal academic / vocational qualification
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
* 5 years).
* In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: * Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
* Good planning and organizational skills to enable effective prioritization of workload
* Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
* Capable of working effectively in a changing environment with complex/ambiguous situations
* Familiarity with the practices, processes, and requirements of clinical monitoring
* Good judgment and decision making skills
* Effective oral and written communication skills, including English language proficiency
* Capable of evaluating workload against project budget and adjusting resources accordingly
* Sound financial acument and knowledge of budgeting, forecasting and fiscal management
* Strong attention to detail
* Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
* Good computer skills to effectively use automated systems and computerized applications such as
* Outlook, Excel, Word, etc. Management Role: * No management responsibility Working Conditions and Environment: * Work is performed in an office environment with exposure to electrical office equipment.
* Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: * Frequently stationary for 6-8 hours per day.
* Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
* Frequent mobility required.
* Occasional crouching, stooping, bending and twisting of upper body and neck.
* Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
* Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
* Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
* Frequently interacts with others to obtain or relate information to diverse groups.
* Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
* 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.
* Regular and consistent attendance.

Keywords: PPD Inc., Wilmington , Study Manager (CTM), Client Dedicated - Oncology/Vaccines, Executive , Wilmington, North Carolina