Clinical Trial Manager - USA

Linical is seeking a Clinical Trial Manager to oversee clinical study activities and deliverables. The role manages study start-up, clinical monitoring, regulatory compliance, CRA performance, vendors, budgets, milestones, and communications while ensuring adherence to protocols, ICH GCP, SOPs, and applicable regulations.

Responsibilities

Develops the Site Activation Plan and customizes study start-up documents as needed

Coordinates site identification, selection and recruitment

Oversees initial regulatory document collection and review

Oversees regulatory and ethics submission processes

Preparation and/or review of essential study documents, e.g. Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form, etc

Authorizes release of Investigational Product

Coordinates site contracts and budgets negotiation and participates in the management of investigator payments

Manages project milestones (for clinical deliverables) and proactively addresses deficiencies:

Holds study team members accountable to the study timelines and Time Entry Guidelines

Provides input to the PM in preparation for Monthly Project Reviews

Attends and provides information at Client teleconferences/study team meetings

Manages CRA performance:

Delegates and oversees work for assigned CRAs

Develops the Monitoring Plan (MP), tools, and training materials

Ensures assigned CRAs receive therapeutic and project-specific training

Oversees the study monitoring visit schedule to ensure compliance with the frequency set forth in the MP

Assists the PM and line management in projecting CRA staffing needs, and managing CRA staff utilization

Reviews and approves visit reports, follow-up letters, expense reports and timesheets within the required timeframes

Schedules and manages CRA project team meetings (and meeting minutes)

Performs quality assessment visits as required

Performs remote review of clinical data within the EDC system to identify trends in enrollment and data entry issues at sites; proactively interfaces with clinical monitoring team and Client to identify solutions and to ensure the data is always consistently monitored/source data is verified at all times

Participates in the performance appraisal process by providing timely and accurate feedback regarding the performance of assigned CRAs

In the event of a CRA change, ensures a thorough and effective handover, documenting per SOPs

When regulatory lead is not assigned, the CTM ensures regulatory documents for assigned countries are filed according to the guidelines in the Trial Master File Plan

Performs the periodic TMF QC reviews for assigned countries and sites

May participate in Vendor Management:

Manages the budget negotiation and contracting process for clinical vendors

Ensures clinical vendors meet deliverables per timeline and budget

Oversees quality of clinical vendor deliverables

Manages Project Finances:

Assists the PM in review of the study budget and expenses to ensure financial targets are met

Reports completion of project deliverables to ensure accurate revenue recognition

Reviews vendor invoices for accuracy prior to payment

Assists the PM in generating changes in scope and notifying the Client of changes, as needed

Performs monitoring of assigned sites as required

Attends and contributes to investigator meetings, Kick-Off meetings and project meetings

Assist CRAs for on-site audits if needed

Other duties as assigned

Preferred

Previous experience in personnel management preferred

Previous experience as a CRA preferred

Personnel Management

Clinical Research Associate (CRA) Experience

Benefits

PTO

Comprehensive benefits

Company

Global contract research organization for full-service drug development.

Osaka, Osaka, JPN

http://www.linical.com/

Founded in 2005

501-1000 employees

Qualifications

Excellent written and verbal communication, presentation skills, conflict management, time management, organizational, interpersonal, and problem-solving skills

Knowledge of project management techniques and tools and proficient in project management software

Strong team-building skills and the ability to work successfully in a matrixed team environment

Excellent customer service and relationship building skills with the ability to proactively address and prioritize expectations

Excellent working knowledge of ICH, GCP and local guidelines/regulations

Knowledgeable in all aspects of clinical trial conduct, including systems, study financials and procedures

Ability to prioritize and manage multiple tasks, and to delegate responsibility as necessary

Dedication to quality in all work tasks and deliverables

Working knowledge of computer systems, applications and operating systems

Life Science degree, nursing background and/or combination of education / experience

Requires a minimum of three years of clinical trial management experience

Previous experience in personnel management preferred

Previous experience as a CRA preferred

Required skills

Clinical Trial Management, ICH Good Clinical Practice (GCP), Clinical Trial Regulatory Compliance, Clinical Trial Financial Management

Preferred skills

Previous experience in personnel management preferred, Previous experience as a CRA preferred

Experience

3+ years