Clinical Trial Manager Job Description

Clinical Trial Manager Job Description

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Clinical trial manager provides operational leadership of clinical research studies to ensure delivery on time, within budget and of high quality in compliance with ICH/GCP, Regulatory Regulations, and applicable SOPs/WPs.

Clinical Trial Manager Duties & Responsibilities

To write an effective clinical trial manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial manager job description templates that you can modify and use.

Sample responsibilities for this position include:

Select and manage CROs and other consultants to ensure adherence to domestic and international regulations and standards (GCP, MDD, ICH)
Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, FRI’s SOPs and policies
Plan, track, and manage all aspects of the trial(s), including budgets
Work closely with the Project Manager from the Clinical Research Organization (CRO) to organize and manage investigator meetings, metrics, ensure SOPs are documented and adhered to, and contribute to the overall documentation of the study
Manage the Contract Resource Organization (CRO) and multiple vendors involved with the planning and execution of the clinical trial(s)
Interact with many cross functional representatives such as
Contribute to resolution of audit findings
Be accountable for input to Informed Consent Templates (ICs), protocols, and case report forms/electronic data capture (EDC) specifications
Interact with many cross functional representatives such as Data Management, Statistics, Clinical, Regulatory, Pharmacovigilance, QA and QC, and Technical Operations
Assists with development and maintenance of processes and systems to optimize efficiency, maximize content reuse and ensure quality

Clinical Trial Manager Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Trial Manager

List any licenses or certifications required by the position: CCRP, CCRC, CCRA, PMP, GCP, ACRP, US, ASCP, CRA, PMI

Education for Clinical Trial Manager

Typically a job would require a certain level of education.

Employers hiring for the clinical trial manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Science, Life Sciences, Medicine, Education, Nursing, Pharmacy, Health, Life Science, Management, Medical

Skills for Clinical Trial Manager

Desired skills for clinical 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
GCP
Clinical Operations processes and tools

Desired experience for clinical trial manager includes:

Participates in industry working groups
Provide oversight to site management activities outsourced to CROs for a number of phase II-IV clinical studies
Oversee planning and site feasibility through study close-out
Participate in CRO oversight plan development and implementation
Review monitoring reports in compliance with Sandoz processes and regulatory requirements
Co-monitor with the CRO as needed

Clinical Trial Manager Examples

1

Clinical Trial Manager Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical trial manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical trial manager
  • Prepare and actively participate as operational lead in internal Project Review meetings
  • Create required project plans
  • Manage all components of clinical trials from protocol inception through CSR completion
  • Performs or oversees CRO pre-site selection and site initiation, interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
  • Participates in overall project planning and execution for clinical protocols
  • Manages study team meetings with both internal and external resources
  • Assists in the development of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters and other written clinical documents
  • Assists in the management of Contract Research Organizations (CROs), vendors, and contractors to ensure project requirements are met
  • Responsible for the overall management of the project Trial Master File
  • Responsible for on-site monitoring of the project as appropriate
Qualifications for clinical trial manager
  • Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions
  • Ability to manage delegated aspects of assigned clinical trials
  • Ability to manage CROs and clinical study vendors
  • Ability to influence and collaborate with cross functional clinical study teams
  • Proficiency in MS office including Word, Excel, PowerPoint and other applications
  • Bachelor’s level degree in life sciences, pharmacy or nursing
2

Clinical Trial Manager Job Description

Job Description Example
Our innovative and growing company is looking for a clinical 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 clinical trial manager
  • Participate in the review and update of existing procedures and develop new procedures as needed
  • Develop and maintain clinical project timelines
  • Lead study team meetings and update stakeholders on a regular basis of study timelines and activities
  • Participate in preparation of Regulatory submissions as required
  • Perform other related duties as required to support Director of Clinical Operations and Cerus goals
  • As the operational study lead, serves as the primary representative of Clinical Operations to Clinical Affairs and other functions supporting the execution and delivery of an assigned study(s)
  • Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues
  • Accountable for accurate and timely entry of study information
  • May lead cross-functional study team (s) and/or sub-team(s)
  • May perform studies following some Phase 2-3 processes when applicable (multicenter-multicountry Phase 2a trials)
Qualifications for clinical trial manager
  • Demonstrated adaptability, handles day to day work challenges confidently, is willing and able to adjust to multiple demands, shifting priorities
  • A minimum of a Bachelor’s or equivalent University degree
  • Ability to operate with limited day to day supervision
  • Proficiency in English language (both oral and written)
  • Demonstrated flexibility and ability to lead global/regional teams in a virtual environment
  • Coach and mentor to junior staff
3

Clinical Trial Manager Job Description

Job Description Example
Our company is looking to fill the role of clinical trial manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical trial manager
  • Conducts CRA Training
  • Lead the clinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study
  • Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility
  • Ensure proper overview and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures
  • The Dedicated Project Expert (DPE) is accountable for operational oversight of the clinical program conducted within Trial Operations
  • Evaluating and monitoring project progress and resources to ensure projects are on time and within budget
  • Interacting with various internal and external customers to facilitate successful project completion
  • Assessing and upgrading the service level of project management with suggestions on new tools, processes, procedures
  • Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT)
  • Create appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed
Qualifications for clinical trial manager
  • Ability to negotiate with vendors and teams
  • 5+ years’ managing sponsor companies
  • 5+ years’ managing timelines and budgets
  • 2+ years’ dermatology
  • Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
  • Must demonstrate leadership skills in order to guide and manage company commitments to clinical trial disclosure
4

Clinical Trial Manager Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of clinical trial manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical trial manager
  • The incumbent will be responsible for all regional study management aspects of a clinical study including but not limited to all the tasks specified below
  • Manages personnel in daily activities relating to case processing activities providing guidance and support to team members
  • Monitor team member ICSR quality and compliance, with an emphasis on SUSARs accuracy, completeness
  • Monitor defined Quality Control procedures
  • Performs performance management activities, including establishment and monitoring progress of team member goals and objectives, staff development plans, and execution of those plans for direct reports
  • Provide strategic resource planning with counterparts to manage intermittent bolus activities, such as SAE Reconciliation and interim/end of study unblinding activities escalating resource needs above defined sourcing levels to identify alternate options
  • Provide Subject Matter Expertise in operational case processing activities associated with Clinical trial activities (or other functional expertise)
  • Ensure Case Processing team has awareness of case processing obligations and timelines associated with Clinical Trial Agreements (CTA), Pharmacovigilance Agreements (PVA), Collaboration Agreements to ensure safety data exchange within defined timelines
  • Participate in Pharmacovigilance Operational Team meetings (PVOT)
  • Provides strategic leadership to Managers and staff within Case Processing, GMSO
Qualifications for clinical trial manager
  • Disease/therapeutic area knowledge
  • Cross functional and cross-cultural awareness
  • Ability to appropriately delegate responsibilities (e.g., Internally - when several CTOMs involved on a study/ Externally - in case of outsourced activities)
  • Advanced degree or Bachelor’s degree in a biologic discipline with equivalent job experiences required
  • Bachelor degree in Life Sciences from an accredited College or University
  • Minimum 2 years of independently managing clinical studies
5

Clinical Trial Manager Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical 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 clinical trial manager
  • Supports and deputizes for Global Director Case Processing as Supports Associate Director/Director/Sr
  • Managing the development of clinical trial budgets and the related negotiations with sponsors or contract research organizations
  • Ensuring that the pricing of trial budgets fairly represents the value of the sites' research-related procedures and services
  • Ensuring that Sarah Cannon's value proposition is properly represented and valued in clinical trial budgets
  • Reviewing all clinical trial budgets for accuracy, thoroughness, compliance, and sufficiency
  • Evaluating, hiring, placing, and appraising budget analysts
  • Coaching, mentoring, training, and developing Budget Analysts
  • Resolving budget issues between Sarah Cannon and sponsors or contract research organizations while maintaining enduring relationships
  • Representing the department in budget reviews with executive staff, ensuring that analysts are adequately prepared to present their assigned budgets, and following up promptly on issues assigned by any of the executives
  • Ensuring that the Clinical Trial Management System accurately and clearly reflects budget parameters that are required for revenue recognition, billing, and collections
Qualifications for clinical trial manager
  • Minimum of three (3) years of experience in clinical trial contracts and clinical trial budgets is required, handling all phases of the contract and budget process, including drafting, negotiating, and managing clinical trial agreements and budgets, liaising with internal clients, and acting as the external client contact
  • Minimum requirement for this position is a BSN
  • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO
  • Demonstrated experience managing and mentoring clinical operations team members
  • Minimum 4 years clinical study management experience either leading or a member of the cross-functional study team preferably on global studies (US/EU/AsiaPac)
  • At least 1 year hematology/oncology experience

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