Clinical Program Job Description

Clinical Program Job Description

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Clinical program provides direct care as assigned and complete accurate and prompt documentation in accordance with professional standards, agency and regulatory guidelines.

Clinical Program Duties & Responsibilities

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

Sample responsibilities for this position include:

Develop and review project descriptions, project budgets and associated contracts (e.g., funding, CROs, ) to assure compliance with policies
Communicates with all levels of Sarah Cannon leadership, clinicians, physicians, and ancillary department staff that is essential for program development in the hospital community setting
Develop policies through extensive review of research using evidence based practices for the Medicaid department
Function as liaison for Optum UM training for all specific customer requirements outside of Core UM training by explaining all unique needs of each RFP, reviewing draft training chapters for each customer
Function as Preceptor for all implementations, , support new team members by answering all questions and offering coaching and re-enforcement of training via daily group chat and daily web ex as needed
Work with new team the week before “go live” on case scenarios, to build upon knowledge learned in formal training sessions
Able to develop and execute complex study plans in clinical studies with minimal supervision
Serve as project manager on special projects and initiatives
For GS studies, ability to write study protocols, study reports, and regulatory documents
Experience in managing staff mentoring and developing junior staff is required

Clinical Program Qualifications

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

Licensing or Certifications for Clinical Program

List any licenses or certifications required by the position: PMP, CPR, BLS, FEMA, CADC, IL, CITI, CME, BCPS, AHM

Education for Clinical Program

Typically a job would require a certain level of education.

Employers hiring for the clinical program job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Nursing, Social Work, Medical, Management, Business/Administration, Technical, Health, Psychology, Public Health

Skills for Clinical Program

Desired skills for clinical program include:

Adolescent
Adult
Geriatric stages
Business segment strategies
Departmental and care center standards
Hospital
Policies
Procedures and guidelines regulatory agency standards
Health care industry
Excel

Desired experience for clinical program includes:

Typically requires a BSc in a relevant scientific discipline (or equivalent nursing qualification)
Experience in managing staff mentoring and developing junior staff is desirable
Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents
Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel
Assist Clinical Team Leads with preparation, review, handling, distribution, filing, and archiving clinical documentation and reports according to standard operating procedures

Clinical Program Examples

1

Clinical Program Job Description

Job Description Example
Our company is looking for a clinical program. 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 program
  • Supports external research programs (ERPs) process by reviewing clinical research proposals in accordance with Company policies/procedures, and may provide additional clinical expertise and/or administrative support, as necessary
  • Facilitate and organize team meetings
  • Optimizes the continuum of care and create programs that will reduce the risk of patient outmigration
  • Operates at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise
  • Serves as a primary consultant to senior-level colleagues (eg, Clinical Sub-Team Leaders, Development Sub-Team Leaders, Project Team Leaders, Group Medical Directors and Development Review Committee Chairs), functional leadership and cross-functional stakeholders within and outside of gRED
  • Set and manage goals and timelines for projects encompassed by the IVD strategy
  • Manage and facilitate resolution of clinical trial risks or issues
  • Develop strong working relationships and maintain effective communication within the Clinical Department other functional departments within the company
  • Leading global trials or regions
  • Providing oversight and cross-functional team leadership in the management of study(ies)
Qualifications for clinical program
  • Ability to communicate with Sponsor and CRO management
  • Good project planning and management skills to ensure goals are met under tight timelines, ability to contribute creative and practical solutions to problems
  • Good writing skills and ability to effectively communicate with all stakeholders
  • Strong computer, scientific, and organizational skills, including strong Microsoft office skills
  • Demonstrated ability to plan, develop, implement, coordinate and evaluate/improve multi-discipline group and/or individual programs for patients (children, adolescents, adults, and families) and/or specifically defined patient populations
  • Demonstration of effective team leadership in cross-functional matrix teams
2

Clinical Program Job Description

Job Description Example
Our company is hiring for a clinical program. 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 program
  • Communicate with statewide stakeholders to improve care delivered and to address Medicaid program benefit policy issues
  • Finalize work in a timely manner set by the department's supervisor
  • Providing medical information verbally or in writing to nonclinical audiences
  • Collaborates with LDH staff in other programs and other State agencies in program benefit policy development, planning and implementation
  • Serves as a clinical subject matter expert in the development and review of program benefit policy
  • Develops, reviews, and provides comments on Medicaid material intended for use by vendors, providers, managed care organizations and other partners
  • Leads or participates in assigned quality subcommittees and other workgroups engaged in research, analysis, and evaluation of policy issues or initiatives
  • Leads and participates special projects as requested by management
  • Responds to internal and external communication and requests for information in a timely manner
  • Plan, lead, and facilitate SET (internal) meetings act as the CSL lead for vendor meetings
Qualifications for clinical program
  • Knowledge of basic office technology (phone, copier, fax, scanning)
  • Extensive software skills are required, Internet research abilities
  • Direct analysis to continuously assess and define how members are coming into the denominator (timing and source of data) for 2 Stars HEDIS Musculoskeletal Condition measures
  • Profile the ART and OMW denominator and develop specialized initiatives for each unique subgroup
  • Define and continuously refine market collaboration efforts for OMW and ART
  • BA/BS degree, preferably in the life sciences
3

Clinical Program Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of clinical program. 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 program
  • Coordinate clinical program teams to establish processes for measuring and comparing program performance
  • Organize, display and report data in a manner that facilitates the planning, development and evaluation of projects and programs as directed by the Sr
  • Support development and execution of standard system external clinical benchmarking system, in partnership with finance productivity leaders and analysts
  • Provide expert consultation to local clinical and finance leaders regarding using the productivity benchmarking system corresponding budget targets, construction and management
  • Serve as official liaison to regional and local analysts leadership in all aspects of system productivity and budget management
  • Partner with finance and clinical leaders on performance and reporting of productivity, budget, and variance management
  • Design, implement and evaluate new processes aimed at maximizing system productivity benchmarking reliability and effectiveness
  • Collaborate in partnership with Finance, annual benchmarking methodology, objectives, priorities, and target planning
  • Remain abreast of market and professional industry trends in resource management and benchmarking
  • Assist in representation of clinical productivity benchmarking performance and issues to clinical and executive leaders
Qualifications for clinical program
  • Minimum 7 years of pharmaceutical clinical research or development experience
  • Five (5) years of quality assurance auditing experience preferred with a minimum of 3 years required
  • 5+ years functional experience with managing clinical trials, including risk assessment and contingency planning
  • Industry experience within in vitro diagnostics (IVD) needed
  • Data management experience highly desirable
  • Knowledge of statistical principles as applied to clinical trials highly desirable
4

Clinical Program Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of clinical program. 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 program
  • Supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval
  • Creates and implements processes to ensure that case report forms are completed and submitted by clinical investigators
  • Oversees operation to ensure all necessary documentation, including contract agreements are executed, signed and archived
  • Prepares and submits domestic and international clinical study-related applications/notifications including IDEs, Competent Authority notifications when clinical trials will be conducted in the European Union, and other regulatory authority applications/notifications when the trial will be conducted in other geographies
  • Conducts critical assessment of relevant scientific literature for development of Clinical Evaluation Reports for design dossiers and technical files in accordance with EU requirements
  • Provides clinical expertise during the process for product life cycle risk management, including input into the risk management analysis, as necessary
  • Reviews marketing materials to approve content, including claims related to procedure- or device-specific performance, clinical outcomes, and economic value
  • Supports audits by Regulatory Authorities or internal audit teams, Corrective and Preventative Actions, Health Hazard Evaluations, or other Quality, Regulatory, or Clinical improvement initiatives
  • Prepares reports and analysis associated with the institutions core measures programs senior management reports, departmental and clinical service program evaluation, quarterly reports, etc
  • You will provide global medical and scientific leadership in the development and implementation of strategy relating to development assets for the treatment of the complications of diabetes, including diabetic retinopathy and diabetic macular edema, retinal diseases in general
Qualifications for clinical program
  • Interaction with investigator sites
  • Understands and applies scientific principles to trial design data acquisition, analyses, and reporting
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements
  • Minimum of 3 years industry related experience
  • 3+ years of experience with government procurement and RFP proposal development
  • 3+ years of experience with pricing development and proposal negotiations
5

Clinical Program Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical program. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical program
  • Assists in the development of processes and policies to support information management regulatory requirements
  • You will lead the cross-functional medical subteam and take over the clinical development responsibility for the projects assigned, definition of targeted product profiles, clinical development plan elaboration
  • Update and compose web site content, program newsletters and other outside marketing and education materials, and social networking
  • Coordinate writing and publishing of reports, journal publications
  • Provides leadership for staff, families, and others associated with the service
  • Builds a team of quality mental health professionals
  • Manages daily operations and all service delivery components of the Family Centered Treatment© model Wraparound services
  • Provides supervision to Clinical Supervisors in 6 Service Planning Areas of LA County
  • Oversees administrative staff and functions
  • Creates and implements marketing plan and develop business contacts
Qualifications for clinical program
  • 8+ years of Clinical Program Management experience within a pharmaceutical or clinical research environment
  • Strong interpersonal and communication skills to identify issues
  • Experience working with large data repositories and/or relational databases, , experience with data mining
  • Comply with project or task timelines to support overall success in project milestones
  • Leading clinical team or programs with demonstrated positive outcomes
  • Demonstrates strong current knowledge of the healthcare environment

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