Director, Clinical Job Description
Director, clinical
provides expert QA advice to Clinical Operations based on the analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices.
Director, Clinical Duties & Responsibilities
To write an effective director, clinical job description, begin by listing detailed duties, responsibilities and expectations. We have included director, clinical job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure practice and Clinical Operations maintain all Regulatory Accreditations and Certifications, as required by Federal, State, Local and Specific Agencies
Direct the implementation of and monitor our compliance with policies, procedures, and standards of practice consistent with corporate and external regulatory guidelines
Partners with other colleagues in GTMM for administration of SOPs/WPs which will facilitate execution & oversight of both in-house and outsourced clinical trials/programs compliant with ICH/GCP standards
Establish appropriate lines of communication, authority, and accountability as directed for the clinical operations
Ensure the maintenance of equipment used in surgery and any ancillary equipment is done regularly and according to regulatory and/or accreditation standards
Review all related documentation and provide input
Provide training and consultation to staff, families and providers including ongoing organization and conducting of CETs
Assist coordinators with preparation for coordination certification
Participate in recurring team meetings as necessary
Develop behavior support plans as necessary for guests at the resource center who require more extensive safety measures
Director, Clinical Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Clinical
List any licenses or certifications required by the position: BCLS, CPR, CPI, BLS, PMP, START, URAC, NCA, ASCP, ICANL
Education for Director, Clinical
Typically a job would require a certain level of education.
Employers hiring for the director, clinical job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Nursing, Management, Education, Performance, Communication, Supervision, Computer, Graduate, Business, School of Nursing
Skills for Director, Clinical
Desired skills for director, clinical include:
GCP
Microsoft Office programs
Interpreting existing benefit language and policies in the process of clinical coverage reviews
Good Clinical Practices
Statistics
Clinical operations
Basic and clinical science
Budgeting
Regulatory
Medical terminology
Desired experience for director, clinical includes:
Participate in discussion regarding potential resource center admissions
Provide oversight of therapeutic groups/activities and onsite consultation as needed for guests receiving center based and/or mobile supports
Experience supporting revenue generation activities by developing curricula for new educational initiatives and business opportunities preferred
Prior experience in a non-governmental organization (NGO), government agency, or private organization
Intuitive, yet grounded
May lead meetings (face-to-face, teleconferences, ) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently
Director, Clinical Examples
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Director, Clinical Job Description
Job Description Example
Our growing company is looking to fill the role of director, clinical. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for director, clinical
- Support execution of clinical studies/post marketing research programs, interpretation of results, and preparation of oral and written internal/external presentations, including FDA or Regulatory body submissions external review bodies (e.g., co-license partners and Jansen affiliates)
- Strategically align and partner with individuals and groups within and outside Medical Affairs (e.g., GCDO, R&D, Global Medical Affairs, Regulatory Affairs, Clinical Compliance) for critical issues resolution related to clinical and outcomes programs and operations, compliance with training requirements, and audit
- Achieves the outcomes of the organization in relation to core measures, regulatory influences, pay for performance, HCAPS, staff and customer satisfaction and identifies areas for ongoing growth and development
- Lead the clinical trial protocol development process by independently translating the Clinical Development Plan strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents supported by appropriate external
- Lead and direct population health strategies and care coordination activities
- Manage all quality-driven value-based payment programs to ensure maximum incentive reimbursements
- Assist in the monitoring and analysis of clinical quality data
- Confirm a Quality Management System (QMS) is developed, implemented and maintained, for all phases of testing, to include the pre-analytic, analytic, and post-analytic phases of testing general laboratory systems
- Partners with senior leadership in monitoring, GTMM and CIQM to develop and implement Quality management system for monitoring with a keen focus on creation of metrics, key quality and performance indicators
- Leverages analytics to perform trend analysis of monitoring information on in-house and outsourced studies to identify gaps in performance and quality
Qualifications for director, clinical
- Facilitate ongoing improvement of research approaches in translational and clinical pharmacology
- Represent Clinical Pharmacology on project teams and in governance proceedings
- Requires an MD or DO degree, preferably board eligible
- At least 3 years of clinical development experience in the pharmaceutical/biotech Industry
- Bachelors degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 15 years of experience managing a manufacturing team in the biotechnology or biologics industry, preferably with 5+ years as a leader of leaders
- Previous cell culture experience preferred/highly desired
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Director, Clinical Job Description
Job Description Example
Our company is hiring for a director, clinical. 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
- Recommendation of incentive and compensation plans for field nursing personnel
- Development and maintenance of relevant clinical education management policies and procedures
- Provide mentorship and coaching for all Clinical Educators
- Support and enhance each employees achievement and desire to attain career development milestones
- Effective and timely communication to clinical teams and the region as determined by VP, Regional Director and Clinical Director
- Management of the field budget and conscientious in the use of travel expenses of the clinical team
- Active involvement in the creation and implementation of the Global Sales Meeting and regional sales meetings
- Understand and have the ability to interact with the internal corporate processes and people required to create and implement successful Home HD Programs, patient growth, retention and product launches
- Responsible for strategic oversight for multiple therapeutic area products across portfolio for conduct of all Medical Affairs clinical trials/post marketing research and other Clinical Affairs activities such as steering committees, data safety monitoring boards, investigator meetings, and division meetings
- Oversee franchise clinical initiatives (program quality, tracking against financial targets, timelines, functional resource allocation in alignment with franchise strategy, clinical processes ) in collaboration with functional leadership
Qualifications for director, clinical
- 7 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization or Academia
- Manage several trials in parallel with multidisciplinary trial teams in a matrix organization
- Demonstrates ability to establish strong scientific partnership with key investigators
- Resolve issues with minimal supervision and understand when to escalate
- Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data
- Master's degree in Social Work from accredited School of Social Work and licensed as a LCSW
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Director, Clinical Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, clinical. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, clinical
- Challenge appropriately the study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost
- Is key role to organize/contribute and/or participate in Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations)
- Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team
- Secure CSD trial master file documents readiness and availability, and mandatory trainings linked to the function
- Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
- Key role with Medical Writer to develop, review and finalize study protocols and reports
- Maintain medical expertise in the therapeutic domain
- The CSD participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required
- The CSD may endorse the role of DPE, where he/she is the key medical reference for the compound in Medical Operations, ensures uniform, aligned operational approach (eg harmonizing study documents, ES, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other CSDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
- The DPE-CSD may have a mentoring and/or supervising role of more junior CSDs and Clinical Scientists supporting the studies within the same project or in the same therapeutic area/indication that he/she is in charge of
Qualifications for director, clinical
- Strong project management skills and decision making skills
- Registered Nurse with greater than 5 years ICU or ED clinical experience
- Expereince preparing analytic reports, MOR and TEAM assignment
- Proficient with Microsoft Excel spreadsheet development, PowerPoint presentations
- Experience taking strong cross functional leadership role in Phase 2 to 4 clinical development
- Advanced understanding of clinical development and/or marketed support such that the employee is able to recommend, influence, and implement improvements to these processes
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Director, Clinical Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of director, clinical. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for director, clinical
- Lead clinical testing and design for clinical observations and trials
- Work with scientists to manage hypothesis driven research for publication with clinical trial sites
- Keep up to date with innovations in infectious diseases applications and technology in the assigned areas via the above mentioned global network, via contacts with end users and researchers, scientific literature, symposia and international conferences
- Major element in this task is the set-up and maintenance of the clinical roadmap for the assigned area
- To define and participate actively in clinical research- and concept & feasibility projects for the assigned application, both in-house and with external clinical partners, to be able to support decision making for new development projects
- To ensure that the medical equipment that is used meets future needs of hospital specialists
- Support and management of daily operations of office and field based nursing staff to ensure timely and effective telephonic and face to face assessments are performed
- Demonstrate knowledge and application of State contracts and manuals to ensure all service coordination processes are meeting contractual and performance measures
- Research and define operational effectiveness within the team to generate innovative ideas that advance the efficiency and effectiveness of the clinical programs
- Demonstrate data-driven, solutions-based on orientation to drive results for our clients/customers
Qualifications for director, clinical
- Strong communication skills (including writing and presentation skills) with success in influencing all levels cross functionally
- Proven leadership abilities in a highly complex and fast paced environment where negotiation skills were essential for success
- Experience working with corporate partners would be an advantage
- Requires full range of body motion including handling and lifting items that weigh up to 50 pounds
- Requires corrected vision and hearing to within normal range
- Advanced experience in programming tools such as SAS, R, PL/SQL, Perl, Python
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Director, Clinical Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of director, clinical. 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
- Create and define overall outsourcing strategy, including potential preferred provider relationships, negotiated rate cards, volume discounts
- Create and maintain outsourcing/vendor oversight standards and templates
- Partner with Finance to create standard vendor budget and SOW templates
- Facilitate vendor invoice review and approval process by study teams
- Track vendor contract timelines
- Ensure completion of vendor close-out activities and final financial reconciliation at end of engagement
- Plan, develop, and implement recruitment strategies and oversee all duties involved in the recruiting, screening, interviewing, and hiring of healthcare providers
- Execute recruitment plans by aggressively recruiting for well-qualified candidates from a variety of sources
- Ensure that all involved parties hiring clinical talent are compliant with current hiring processes
- Oversee Senior Recruiters’ day to day candidate sourcing activities and ensure they are working towards defined goals and objectives
Qualifications for director, clinical
- Nursing management experience essential
- Preferably CNN
- Willingness to participate in professional Nephrology organizations
- For chronic positions, preferably home hemodialysis training experience
- Experience of at least 3 years in industry - medical devices preferably
- Demonstrated ability to manage a wide variety of management issues/projects conducting financial, business and budget planning