Director, Clinical Operations Job Description

Director, Clinical Operations Job Description

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Director, clinical operations provides leadership to financial and contractual aspects of the project, including general financial management and processes, subaward financial management, and accounting;.

Director, Clinical Operations Duties & Responsibilities

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

Sample responsibilities for this position include:

Administering, directing, planning and coordinating business and clinical activities at multiple medical offices/departments
Working collaboratively with the Medical Group physicians to ensure high quality, cost effective and accessible patient care services
Administering the patient/nursing services across the organization
Supervise clinical teams
Assume responsibility and have authority for maintaining the quality of patient care for all clinical services
Manage and execute Agency objectives, standards of care, policies and procedures affecting clinical services and dependencies
Participate in on-going strategic planning work through collaboration with the CEO and Director of Business Development
Define authority, functional responsibility lines of reporting and communication for nursing, all therapies, social service and home health aides
Manage and direct evaluation of the clinical operations of assigned staff
Monitor and analyze monthly statistical data, outcomes, and productivity reports

Director, Clinical Operations Qualifications

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

Licensing or Certifications for Director, Clinical Operations

List any licenses or certifications required by the position: BLS, CPC, PMP, CPR, BCLS, PALS, ANCC, APICS, CPI, CCRP

Education for Director, Clinical Operations

Typically a job would require a certain level of education.

Employers hiring for the director, 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 Nursing, Management, Health, Public Health, Business, Science, Health Care, Healthcare Administration, Education, Supervision

Skills for Director, Clinical Operations

Desired skills for director, clinical operations include:

Budgeting
NCQA
Clinical research financial parameters and project financial tracking and accounting methods
Applicable business tools and systems
Databases
Financial concepts as related to forecasting
Proposal generation
Spreadsheets
Word processing and statistical software programs
GCP

Desired experience for director, clinical operations includes:

Provide direct care to patients as appropriate
Report to the Head of Early Development, Infectious Diseases
Be responsible for operational implementation and execution of early clinical development programs
Participate in a number of Development Teams and other cross-functional forums that determine clinical strategy within the Infectious Diseases Therapeutic Area
Be involved in the planning and execution of clinical trials across multiple programs within established timelines and budgets while ensuring regulatory compliance
Determine the best clinical operational model for executing the Infectious Diseases Therapeutic Area clinical development programs

Director, Clinical Operations Examples

1

Director, Clinical Operations Job Description

Job Description Example
Our growing company is looking to fill the role of director, clinical operations. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, clinical operations
  • Work closely with other groups within Janssen to plan for and to ensure continuity of programs as they transition from early to late stage development
  • Assures clinic perform with high standards of care, measure and improve clinical work flows, and implement standard best practices
  • Manages clinical space utilization and requests
  • Promotes practice growth and collaboration between BCM and CHI/St
  • Work effectively with the organization’s clinical affiliates (notably, CHI St Luke’s Health System and related clinically integrated networks) to support a functional regional vertically integrated health system
  • Monitors patient satisfaction reports and results (Press Ganey and others) and develop plans by which clinical operations teams can contribute to the improvement of our health care facilities
  • Standardizes faculty practice operations, processes, policies and procedures
  • Manages studies of products independently and resolves simple to complex issues to move clinical development of products forward
  • Trains internal and third party team members as appropriate to meet business needs
  • Cultivates a strong and transparent working relationship with the Executive Team and ensures open communication about the measurement of financial, programmatic, and impact performance against stated milestones and goals
Qualifications for director, clinical operations
  • Manage the progress of clinical studies and ensure adherence to the protocol, timelines, and budget
  • Develop and manage clinical trial budgets
  • Develops key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools
  • Relationship Management – Must be able to manage the relationship with CROs and other service providers that includes clinical study site staff, such as investigators, study coordinators, pharmacists, other relevant functional team members
  • Minimum of 8 years of experience pharmaceutical or biotechnology drug development experience
  • Experience managing clinical quality activities and knowledge of clinical operations
2

Director, Clinical Operations Job Description

Job Description Example
Our innovative and growing company is looking for a director, 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 director, clinical operations
  • Assimilates information from variety of sources, able to analyze data and make recommendations and executes a course of action
  • Provides leadership in guiding specific hospitals, hospital systems, IDNs, and Parallon Business Solutions as it relates to clinical pharmacy services strategy
  • Assist in developing and achieves established targets
  • Develops, implements, and coordinates within the hospital or system policies and procedures related to implementation of clinical pharmacy operations
  • Support external pharma/biotech audits
  • Work directly with pharma/biotech customers to carry out assay validations and early phase clinical studies
  • Develops and manages study budget and maintains it within financial goals
  • Work with staff to make sure all study management and project/program/portfolio deliverables are completed per Contract, to achieve quality deliverables on time and within budget and in accordance with SOPs, policies and practices
  • Obtain regular feedback on employees from other clinical project team members and key stakeholders to facilitate ongoing performance management and development
  • Direct, manage and mentor an assigned team of Clinical Operations staff who lead and/or manage those who lead studies or programs
Qualifications for director, clinical operations
  • BS/BA degree in a scientific or medical discipline
  • Ability to perform medical literature reviews, interpreting and presenting scientific/clinical trial data
  • Strong knowledge of Good Clinical Practices including US 21 CFR and ICH E6
  • College degree in the life sciences required
  • Considerable periods of time may be spent concentrating and or analyzing data
  • Experience with clinical trial systems (CTMS, EDC, IVR, ) and clinical trial processes
3

Director, Clinical Operations Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of director, clinical operations. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, clinical operations
  • Direct the delivery against key metrics, milestones, and contractual obligations for a portfolio of projects to encompass expectation setting and management against quality, time and financial objectives
  • Serve as the primary operational management contact globally to the designated customer account
  • Lead the review of a customer pipeline, opportunities pending, and future customer needs in support of the quarterly development of resource forecasts for delivery to the cost centers providing resources to the designated customer account
  • Act as the key relationship manager for designated customer
  • Team member responsible for participation in the development and support of customer sales initiatives
  • Provide strategic clinical operations oversight and direction ensuring collaboration across a project(s) to translate our science into reality through high quality clinical trial conduct
  • Ensure the activities that impact projects are executed according to the clinical development plan
  • Develop and execute program-specific project and risk management plans (milestones, metrics, critical path) ensuring and appropriate escalation as needed
  • Set program-level enrollment strategy including country and site selection plan and timelines to meet program objectives
  • Ensure program-level Investigational Product supply strategy meets the needs of the clinical program (s)
Qualifications for director, clinical operations
  • Experience of Clinical Trial execution, either as Operations or one of the support groups
  • Experience of developing or using technologies designed to enable efficient execution of clinical trials
  • Experience of enterprise architecture a plus, but not a requirement
  • Project management experience in the eClinical/Technology or Clinical Trials domain a plus
  • Must have previous start-up and overall mgmt
  • In-depth experience within clinical research with specialist experience in leadership and senior management
4

Director, Clinical Operations Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, 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 director, clinical operations
  • Partner with Quality Assurance to develop the strategic plan for regulatory audits and inspections
  • Evaluate study-level issues for broader impact (e.g., cross-study, ) in a timely fashion and ensure resolution
  • Key contributor to a project or program documents
  • Represent the clinical operations function at advisories, interactions with regulatory agencies and evaluation of business opportunities (due diligence)
  • Participate in resource prioritization across teams to ensure clinical operations strategic goals and milestones are achieved
  • Matrix management of a team of clinical operations personnel assigned to plan, implement and execute clinical trials
  • Strategic planning and execution of a project(s) in collaboration with the therapeutic area and relevant groups
  • Effective clinical operations oversight to ensure on time delivery of project(s) within the pipeline
  • Core member of strategic governance body (e.g., GPT), interacts with all functions supporting clinical development
  • Responsible for developing and managing project budget (typically up to $500MM)
Qualifications for director, clinical operations
  • Minimum of 10-12 years’ experience in clinical research and at least 5 years of experience managing clinical research teams in Argentina
  • Significant clinical trial management experience with demonstrated success required
  • Positive proven success in people management and project management
  • Working knowledge of MSD’s core business structure and how own function contributes to and works within the organization
  • Ability to think cross-functionally and working across boundaries internationally
  • Demonstrated ability to build relationships with senior business executives
5

Director, Clinical Operations Job Description

Job Description Example
Our company is growing rapidly and is looking for a director, clinical operations. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, clinical operations
  • Manage and analyze external regulatory outcome data reports
  • Conduct regulatory related education/training programs for all levels of the organization
  • Facilitate / coordinate resources for communities in need of additional regulatory compliance support
  • Maintain current knowledge of current/proposed federal and state regulations and communicate to all levels of the organization
  • Partner with DDH and RDH team to implement programs (SNF/HC & AL)
  • Coordinate and manage clinical program/policy manuals (HC/SNF, AL, IC, Orientation, Medical Records)
  • Regularly monitors accrual rates at sites to determine if sites are meeting requirements (ACoS, Alliance, NAPBC)
  • Establishes relationships with Duke Investigators to promote trial sharing
  • Evaluates the feasibility of proposed studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies
  • Coordinates and establishes clinical trials schedules, task assignments and allocation of manpower and equipment to ensure conformance with specified objectives
Qualifications for director, clinical operations
  • Bachelors Degree or international equivalent required, Life Sciences preferred
  • Fluency in English, Spanish is required and Portuguese is desirable
  • In-depth experience working on clinical trials with established experience in a leadership capacity across a portfolio of work
  • Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm and commitment, and to gain approval/sponsorship for projects
  • Minimum 15 years pharmaceutical industry experience required
  • Global experience and leadership experience required, preferably with oncology project development

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