Associate Clinical Trial Manager

Mallinckrodt; Malvern (Chester County); On-site; USD 110,000 - 140,000; Full time

Job summary

Mallinckrodt in Malvern, PA seeks an Associate Clinical Trial Manager to assist the Clinical Trial Manager in leading study teams, ensuring studies are delivered on time, within budget, and with high quality, in compliance with GCP and ICH.

The role collaborates with the Clinical Development Lead, Data Management Lead, Regulatory Lead, Clinical Supply Lead, Biostatistics Lead, and Medical Writing Lead; supports TMF maintenance and vendor oversight, including CROs and labs.

Qualifications

• GCP knowledge and ICH guidelines awareness required.
• Experience with budget planning and cost control for clinical studies.
• Vendor management experience including CROs and central laboratories preferred.

Responsibilities

• Execute and oversee study activities with adherence to GCP, ICH, and Keenova SOPs.
• Monitor and manage study budgets, timelines, and risk mitigation.
• Coordinate with cross-functional teams and external vendors to ensure on-time deliverables.
• Maintain and oversee study documentation and TMF."
• Support study planning, site selection, and vendor oversight.

Skills

GCP knowledge

ICH guidelines

Budget management

Vendor management

Cross-functional coordination

Job description

Job Title

Associate Clinical Trial Manager

Requisition

JR000016013 Associate Clinical Trial Manager (Open)

Location

Malvern, PA

Job Description Summary

The 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 CR