Trial Manager Job Description
Trial manager
provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
Trial Manager Duties & Responsibilities
To write an effective trial manager job description, begin by listing detailed duties, responsibilities and expectations. We have included trial manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure assigned trials are inspection-ready at all times
Partner and agree with GPT/ICT/CTT on realistic and stretched project timelines
Communicate planned milestones to GMO stakeholders and update CTTs on operational activities
Lead study allocation process for assigned trials within agreed timelines
Ensure patient recruitment as per plan, including contingency planning and communication of timelines for major milestone deliverables
Ensure clinical data flow as per plan
Drive conduct of medical and operational feasibility
Create the monitoring plan
Review, approve and ensure updates to CCGs as appropriate during trial conduct
Function as a Program Delivery Lead for T&P Programs as assigned to include development & test phases facilitation of trials and deployment planning
Trial Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Trial Manager
List any licenses or certifications required by the position: CCRP, CCRC, CCRA, PMP, GCP, ACRP, US, ASCP, CRA, PMI
Education for Trial Manager
Typically a job would require a certain level of education.
Employers hiring for the trial manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Life Sciences, Science, Nursing, Education, Medicine, Health, Healthcare, Pharmacy, Life Science, Management
Skills for Trial Manager
Desired skills for trial manager include:
ICH GCP and relevant regulations for the conduct of clinical trials
Project management processes and tools
Word and Excel
Clinical research process
Current ICH GCP guidelines and applicable regulations
ICH/GCP
Regulatory guidelines/directives
Drug development and clinical research processes
Good Clinical Practice
Understanding of the overall drug development process
Desired experience for trial manager includes:
Advanced degree or significant relevant experience in life science/healthcare
6 years' experience in clinical research, planning/executing and/or monitoring clinical trials
6 years of experience in clinical research, in planning/executing and/or monitoring clinical trials
Project/trial management and/or CRA or CRA management experience
Communicate with key stakeholders including development teams, operations, product and Sr
Minimum of 5-7 years of program management experience, including leading cross-functional organizations in a complex, technical environment
Trial Manager Examples
1
Trial Manager Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of trial manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for trial manager
- Ensure regional/global clinical operations deliverables against project timelines
- Provide input into cross functional documents Safety related documents, Protocol Deviations and Issue management processes
- Lead compliance activities in line with global health authority regulations/guidelines
- Provide real time deliverable status updates to SMT and Trial team members
- Responsible for managing activities associated with the conduct of assigned clinical trials
- Develop protocols, consent forms, monitoring plans, case report forms and other clinical documents related to clinical trials
- Manage investigational sites to ensure compliance with protocol and overall clinical objectives
- Supervise clinical site monitors (internal and/or contract)
- Assist in the development of investigator brochures and other regulatory documents
- Participate in safety review and reporting
Qualifications for trial manager
- Forge and foster local market relationships to drive trial objectives and achieve associated deliverables
- Act as a point of contact for project status across departments involved with assigned projects
- Ability to work in an unstructured environment, with minimal direction and under aggressive schedules
- Ability to work effectively across organizational boundaries with all levels of personnel
- Minimum of 2-5 years of relevant experience in pharmaceutical packaging and labeling
- Experience with distribution and return processes for IMP
2
Trial Manager Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of trial manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for trial manager
- Manage CRO/study sites
- Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions
- Assess CRO performance by completing CRO post services assessments
- Conduct yearly CRO assessment, if applicable
- Conduct field monitoring activities, if required
- Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review
- Attend site visits as primary or co-monitor
- Conduct source data validation and other monitoring activities (according to the study-specific Monitoring Plan, if applicable)
- Use eCRF tool for ongoing data review and query generation
- Regularly review and reconcile the Investigator Study File, Investigational Product accountability and biological sample management
Qualifications for trial manager
- Knowledge and work experience with GMP and GCP requirements, customs requirements, shipping, IND/NDA, 21 CFR Part 11
- Manages risk and uncertainty
- Able to work under aggressive timelines and prioritize multiple tasks from various parties
- A minimum of Bachelor Degree or equivalent required
- Requires clinical research operational knowledge, strong project planning/management and effective communication skills, Should be flexible and have experience and ability in managing global or regional teams in a virtual environment
- Clinical/medical backgrounds a plus
3
Trial Manager Job Description
Job Description Example
Our growing company is looking for a trial manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for trial manager
- Creating and executing supply strategies in view of changes in trial execution and ensuring a seamless transition from study design phase and assessing clinical study recruitment rates, forecasting for kit demand planning and ensuring supply planning is adopted accordingly
- Utilizing business tools to manage inventories at depots and sites and ensuring on-time delivery with minimal overage of clinical supplies, issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution) and establish and modify trial specific distribution agreements
- Participating as a member of appropriate GCDO clinical trial team, internal collaboration with GCDO stakeholders to ensure customer satisfaction, interfacing with Global Trial Managers
- Managing trial supply specific budget and supporting business process improvement initiatives and all clinical supplies during trial execution within J&J Pharma R&D (large and small molecules and for all phases of clinical trials)
- Conducts local trial team meetings and provides or facilitates SM training when needed
- Acts as primary local/country contact for a trial
- Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, contributing to the development of the quality management system for the area of trial management
- Develops study plan and forecast, including detailed schedule and budget
- Develop and maintain Study Risks management plan
- Define resource requirements and ensure appropriate resourcing (including outsourcing)
Qualifications for trial manager
- Working knowledge of the clinical drug development process
- A degree in a scientific or health care discipline or significant relevant experience preferred
- At least 8 years’ experience in clinical research with 6+ years in Oncology and at least 4 years as a CRA and/or QA auditor
- Knowledge and experience in international (FDA, EMEA) and local regulations Novartis standards
- Ability to apply experience to new situations, such as trending and analysis
- Experience in leading multidisciplinary teams in a matrix environment
4
Trial Manager Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of trial manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for trial manager
- Works with study and/or project teams, ie, clinical, regulatory, marketing, patents and legal, to plan and prepare disclosures, according to current guidelines
- Brings specialized knowledge of global disclosure requirements and standards to teams, in association with a scientific background, providing guidance on best practices to ensure quality of information shared publically, and compliance with defined requirements
- Drives a strong focus in teams and partners on consistency of trial/product information across disclosures and associated areas such as publications and data-sharing
- Provides careful oversight of activities managed in collaboration with Vendor partners
- Due to the rapidly evolving nature of the disclosure landscape, leverages self-study, ongoing learning, to remain abreast of developments in trial disclosure and related fields
- Works effectively with disclosure and disclosure relevant tools used by the Platform
- Depending on experience, may mentor more junior staff members and provide SME representation in varied disclosure-related projects both internal and transversal
- Participate in or lead process improvement initiatives for disclosure
- The employee is responsible for completing all required training to execute their job and maintain their training records
- Other roles may be allocated as appropriate to the incumbent as required to ensure delivery of the clinical studies
Qualifications for trial manager
- Bachelor’s degree in a health profession or science
- Experience managing outside vendors, , CROs and labs
- University/Bachelor’s Degree in medicine, science or equivalent degree
- BS or equivalent experience in a scientific or medical discipline with 5 years clinical trials management experience
- Previous budget and contract negotiation experience
- Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs
5
Trial Manager Job Description
Job Description Example
Our company is hiring for a trial manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for trial manager
- Maintains contract files and systems
- Supports the implementation of contracting-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables
- Implement outsourcing strategies and processes for successful support management of US clinical programs
- Effectively use evaluation tools and provide oversight over CRO/third party vendor performance to address performance issues and ensure high quality deliverables within planned timelines against contracted scope of work (SoW)
- Maintains close working relationship with all of CO Legal, Ethics & Compliance, Clinical Development & Medical Affairs (CDMA), and Global Sourcing
- Manages the day-to-day operations and assists with oversight with contracting vendor(s)
- Represents Contracting group for projects and working groups
- Assists in delivering appropriate training for the Contracting group in partnership with the Training and Compliance group
- Ensures clinical trial investigator budget is of high quality and allocations are within fair market values
- Effectively uses budget-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables
Qualifications for trial manager
- Five years relevant industry, 3 years within the function
- Minimum of Six (6) years clinical research experience in the U.S. biotech/pharmaceutical industry
- University degree in Health Sciences or Life Sciences
- Previous experience as Clinical Project Leader managing more than one country
- Formal training or certificate on Project Management
- Knowledge of GCP/ICH phase I-IV clinical trials