Clinical Operations Job Description

Clinical Operations Job Description

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Clinical operations provides ICH GCP and applicable regulatory training within the organization and at Investigator meetings, as needed.

Clinical Operations Duties & Responsibilities

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

Sample responsibilities for this position include:

Accurate and timely setting up clinical trials in the Clinical Trial Management System according to protocol specifications and trial timelines
Identifying and correcting data discrepancies
Generating trial status updates/reports from Clinical Trial Management System and communicate to team members
Providing support to the Novartis global and local organizations with clinical trial management system functionality and resolution of trial specific queries
Assisting end users with securing access to the Clinical Trial Management System
Actively participating in Clinical Trial Team meetings in order to provide trial updates as needed
Participating in department and staff meetings
Manage the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs)
Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS)
Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, ) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner

Clinical Operations Qualifications

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

Licensing or Certifications for Clinical Operations

List any licenses or certifications required by the position: CPR, BLS, ACLS, PMP, PALS, PMI, ASQ, CRA, AAALAC, CAP

Education for Clinical Operations

Typically a job would require a certain level of education.

Employers hiring for the clinical operations job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Nursing, Education, Health, Life Science, Medical, Pharmacy, Business, Life Sciences, Healthcare

Skills for Clinical Operations

Desired skills for clinical operations include:

Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Basic clinical project financial principles
Basic financial concepts as related to forecasting and budgeting
Microsoft Office applications
GCP/ICH guidelines and other applicable regulatory requirement
FDA
Excel
GCP
ICH GCP
Global regulatory and compliance requirements for clinical research

Desired experience for clinical operations includes:

Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual
Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner
Liaise with study site personnel and clinical investigators to provide study related guidance and answers to operational issues
Ensure timely communication of any variances to budget forecast to the Sr
Provide Clinical Operations support to the Regulatory Affairs department
Manage in-house team of Managers and CRAs for studies to ensure execution of all studies in a timely and efficient manner

Clinical Operations Examples

1

Clinical Operations Job Description

Job Description Example
Our company is hiring for a clinical operations. 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 operations
  • Guides study team in vendor selection and management throughout the life of all assigned clinical projects
  • Identifies and communicates with therapeutic thought leaders for feedback on study protocols, development plans, publications
  • Manages all aspects of a clinical trial authoring the protocol synopsis, final protocol and template informed consent form to site selection, initiation, and study start activities including drafting of study site agreements and negotiating budgets
  • Communicate with the Senior Director and/or VP Clinical Operations, on all critical issues and business growth opportunities
  • Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project
  • Clinical Trial Protocols - Prepare directly or facilitate preparation of protocols including study design, case report forms, study procedures
  • Identify clinical investigators and assess suitability of study sites
  • Direct and ensure the delivery of quality clinical care and exceptional patient services
  • Manage the on-going development, implementation and improvement of quality patient services and compliance with professional standards
  • Plan, manage and implement Staff training and development
Qualifications for clinical operations
  • Effectively work independently within a team matrix
  • Collaborates with internal and external stakeholders, including study site personnel to understand the patient journey the recruitment opportunities associated with achieving the enrollment goals clinical trials
  • Due to the nature of the position, the employee may be required to travel
  • Track and analyse metrics for CRA Management duties
  • Proactively identify and implement process improvement initiatives related to clinical monitoring and site management as appropriate
  • Mentor, coach, and manage team performance by establishing specific goals and objectives
2

Clinical Operations Job Description

Job Description Example
Our growing company is looking to fill the role of clinical operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical operations
  • Develop relationships with vendors to enable mutual understanding of expectations, deliverables and issue resolution
  • Escalate any known vendor/consultant performance issues to line management
  • Develop or maintain vendor governance strategies, providing KPIs and performance measures
  • Maintain vendor database with ongoing vendor performance information and manage issues logs and trackers
  • Work with vendor and clinical trial team members to resolve performance issues
  • Perform lesson learned meetings to capture and utilize best practices
  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST
  • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines
  • Review, establish and agree on project planning and project timelines
  • Ensure monitoring measures are in place and implement contingency plan as needed
Qualifications for clinical operations
  • Ability to work outside normal business hours (CST)Ability to work outside normal business hours (CST)
  • Conduct timely performance reviews and appraisals by acquiring feedback on the manager’s performance from Project Managers, Directors, Clinical Operations and others as required
  • Associate’s degree minimum preferred English
  • Associate’s degree minimum preferred
  • Leads and manages professionals and others through influence and collaboration in single and/or multiple pharmaceutical care programs and sites
  • Knowledgeable of all facets of In- and Out- Patient Pharmacy operations, including clinical, professional, legal, business and public relations
3

Clinical Operations Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical operations
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory and IP Release documents, in line with project timelines
  • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning
  • Perform quality control of documents provided by sites
  • May have direct contact with sponsors on specific initiatives
  • May perform Site Selection Visits if a trained monitor
  • May participate in feasibility and/or site identification activities
  • Identifies and drives project and resource priorities that align with the business objectives and establishes, communicates and executes plans that drive toward goal achievement
  • Facilitates collaboration, cooperation and communication across functions and between team members and ensure that the team achieves stated goals and objectives
  • Manages the identification of potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution ensuring that all project/program issues arrive at a singular conclusion or recommendation
  • Coordinating input from multiple areas or multiple project managers on related projects or programs
Qualifications for clinical operations
  • Understanding of outpatient, ambulatory practice
  • Experience in field resource deployment preferred
  • You must be able to speak and write fluent English
  • A University degree in medicine, science, or equivalent, you will have had a successful career within the CRO/Pharmaceutical industry at a senior, independent and influencing level
  • Excellent leadership skills, developed with a collaborative approach to driving performance and success in the global environment
  • Direct experience in managing a regional Clinical Operations and/or Data Management area of a CRO/Pharmaceutical company
4

Clinical Operations Job Description

Job Description Example
Our company is looking to fill the role of clinical operations. 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 operations
  • Manages and resolves complex issues and escalates them appropriately
  • Assist in communications and training development and implementation
  • Evaluates business processes and organizational initiatives to propose interventions (i.e., change management and communications strategies) to meet organizational goals
  • Creates supporting documentation for organizational initiative
  • Facilitates implementation of communication plans for rolling out initiative throughout organization
  • Functions as a change agent, develops and monitors key metrics for measuring progress of initiative roll-out and staff understanding and acceptance
  • Proposed continuous improvement/process improvements as needed to ensure that initiative achieves intended outcome
  • Takes a high volume of inbound or places outbound calls to provide information and services to customers
  • Utilizes a database to retrieve customer or company information
  • Must be able to learn and follow detailed instructions, use a variety of resources and possess good organizational skills to provide accurate information
Qualifications for clinical operations
  • Proficient understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based)
  • Proficient knowledge of concepts of clinical research and drug development preferred
  • Proficient understanding of contracts and negotiations
  • Bachelor's Degree in life sciences or a related field and 1 year's clinical research or other relevant experience
  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Project management (meeting management, metrics and status reporting)
5

Clinical Operations Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of clinical operations. 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 operations
  • Document needs for customers in databases
  • Must demonstrate patience, tact, empathy and problem solving skills with consistently good voice quality
  • Can organize and handle calls with speed and accuracy
  • Must be able to be available to customers for a certain period of time during the day
  • Can work with complex computer applications and resource materials
  • Can use multiple operating environments (Windows, DOS, Mainframe)
  • The BQ/EQ Scientific Technician II is responsible for performing all testing according to the applicable standard operating procedures (SOP) and meet all cGMP requirements for the testing and associated documentation
  • Communicates to the BQ/EQ Supervisor or BQ Manager of any nonconformance with the laboratory testing or equipment
  • Must have an understanding of microbiological and environmental testing and cause/effect relationships to better determine audit/investigation results
  • Responsible for performing a peer review of testing data and assist with administrative activities for the laboratory
Qualifications for clinical operations
  • Excellent phone and writing skills are a must
  • Previous call center background and pharma experience (working with HCP and physicians) is beneficial
  • Responsible for adhering to all cGMPs, SOPs, and plant policies/rules
  • May also be required to perform audits, assist with investigations, update standard operating procedures, and train new personnel based on the need of the business
  • Bachelor's Degree in Biology or Biological Science (Microbiology preferred)
  • Must have Microbiology coursework w/ lab

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