Job TitleAssociate Clinical Trial Manager
RequisitionLocationMalvern, PA
Additional LocationsJob Description SummaryThe Associate Clinical Trial Manager (ACTM) is responsible to assist the Clinical Trial Manager for study team leadership in one or more cross functional study teams to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities' regulations/guidelines and Keenova's SOPs. This role applies to internally sourced studies and/or CRO/Partnered studies. This role Collaborates and interacts with the Clinical Trial Manager, the Clinical Development Lead, the Data Management Lead, the Regulatory Lead, the Clinical Supply Lead, the Biostatistics Lead and the Medical Writing Lead.
Job Description- Responsible for the execution and adherence of various aspects of the study (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as Keenova's SOPs and policies.
- Responsible for monitoring assigned aspects of the study plans.
- Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation
- Processes input from key stakeholders.
- Supports the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
- Responsible for the management and maintenance of the study TMF.
- Supports the Clinical Trial Lead and Study Team in managing the selection, contracting and oversight of CROs and clinical trial related vendors.
- Coordinates with external service providers including clinical research organizations (CROs), laboratories and others, serving as primary point of contact, collaborating on the scope of work, ensuring agreed deliverables are achieved on time and monitoring key performance indicators.
- Monitors, controls, and reports performance of deliverables against timeline, deliverables, budget and quality expectations.
- Signs documents for activities as authorized and described by Keenova policies, procedures and job descriptions.
Study Team Leadership- Leads cross-functional study team (s) or Assists Clinical Trial Manager depending on study set up.
- Provides input on study protocol in collaboration with other study team members.
- Develops, manages, and maintains relationships with external partners/vendors (such as CRO and/or centralized labs).
- Develops study execution plans and risk management plans.
- Facilitates effective communication between study sites and study team members to ensure ongoing successful execution.
- Mentors CTAs assigned to trial(s)
Study Planning- Serves as main point of contact for Clinical Operations in managing protocol execution or Assists Clinical Trial Manager depending on study set up.
- Assists in the development of study documents including protocols, informed consent forms, and study manuals with input from other functional leads.
- Collaborates with the Clinical Supply Lead to ensure investigational product manufacturing, labeling, release and management is on-time.
- Oversees setup and management of the TMF.
Selection and Evaluation of Investigative Sites- Participates in site selection.
- Reviews feasibility data (site).
- Identifies prospective investigative sites and participates in final investigative site selection.
- Monitors GCP/ICH site level compliance.
Identification and Selection of Vendors- Participates in preparation of RFP, assumptions and SOW.
- Contributes and reviews specs for affiliated vendors
Vendor Management- Oversees all aspects of vendor management (performance, quality, timelines, deliverables, and costs) or Assists Clinical Trial Manager depending on study set up.
- Ensures appropriate escalation of issues as they arise.
- Reviews and approves specified costs on vendor invoices against contract or Assists Clinical Trial Manger depending on study set up.
Preparation of Study Documentation- Reviews essential regulatory documents or oversee Clinical Trial Associate (CTA) review.
- Establishes and oversees risk management process or Assists Clinical Trial Manager depending on study set up.
- Prepares, reviews, and approves Clinical Monitoring Plans.
- Assures adherence to Clinical Monitoring Plans.
- Reviews eCRF specs and reviews CRF completion guidelines.
Input Clinical Database, Safety and CSR Reports- Reviews/edits specifications for EDC
- Executes EDC/IRT User Acceptance Testing (UAT) scripts.
- Facilitates development and review of Data Review Plan.
- Reviews EDC Metrics.
- Participates in data review meetings.
- Participates in SAE reconciliation.
- Reviews CSR and may assist in the compilation of appendices.
Initiation and Site Start Up- Prepares and reviews material for investigator meetings and CRA Training.
- Conducts CRA training or Assists Clinical Trial Manger depending on study set up.
- Assists in planning/organizing/leading Investigator meeting.
- Oversees site IRB approval.
- Authorizes investigational product shipment to investigational sites, including the initial shipment in line with Keenova SOPs.
- Develops and facilitates cross-functional reviews and approval of informed consent forms (e.g. site or country specific ICFs).
Enrollment of Subjects- Ensures enrollment is tracked and recorded appropriately.
- Compiles and reports enrollment status to Study Team.
- Assist in developing and updating recruitment strategy.
- Addresses enrollment and retention issues.
Maintenance of Sites, Subjects and Data- Provides oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced).
- Reviews and approves monitoring trip reports or Assists Clinical Trial Manger depending on study set up.
- Schedules and conducts CRA meetings /teleconferences.
- Follows up on outstanding eCRFs and data queries.
- Oversees resolution of study conduct issues.
- Addresses site issues found during audits.
- Compiles materials and data to support Data Safety Monitoring Board (when applicable).
- Ensures ongoing reconciliation of TMF.
Study Close Out- Manages/oversees study close out activities.
- Ensure TMF archived in timely manner at study end.
Education & Experience- BS degree in biology, allied health, nursing or related life science, advanced degree a plus.
- 3 or more years related experience in clinical study execution.
Knowledge- In-depth knowledge of clinical drug development processes and experience applying GCP, ICH and FDA requirements.
- Solid knowledge of clinical research study processes; ability to incorporate and adhere to GCP and regulatory standards. Ability to develop study processes in support of a clinical trial design.
- Demonstrates solid knowledge in several areas related to clinical research: human anatomy subject protection, regulatory requirements, study design, study execution.
Skills & Abilities- Skilled in implementing tools for effective study management, cultivating relationships with healthcare professionals and cross-functional co-workers, identifying and implementing solutions to address study issues, overcoming obstacles, maintaining composure, and identifying and adapting to shifting priorities and competing demands.
- Excellent written and verbal communication.
- Ability to generate concise summaries for different audiences, professional correspondence, presentations, reports, and training materials.
- Literacy in word processing, spreadsheets, and databases applications (e.g., MS Word and Excel).
- Demonstrated strong skill sets in project planning, and clinical trial execution.
- Skilled at developing project timelines and milestones and working with team to ensure milestones are met; adjusts appropriately when needed and communicates risks when necessary.
- Ability to identify and articulate risks and benefits of plan.
- High attention to detail and accuracy; ability to ensure data accuracy and review data.
Physical Requirements- Standard office environment and daily commute to assigned office location.
- Business travel ~ 25%
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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