Clinical Operations Job Description
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:
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:
Desired experience for clinical operations includes:
Clinical Operations Examples
Clinical Operations Job Description
- 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
- 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
Clinical Operations Job Description
- 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
- 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
Clinical Operations Job Description
- 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
- 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
Clinical Operations Job Description
- 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
- 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)
Clinical Operations Job Description
- 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
- 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