Director, Clinical Resume Sample
Christine Mills
41823 Vincenza Track,
Detroit,
MI
+1 (555) 656 8501
Work Experience
Director, Clinical Affairs
10/2017
-
PRESENT
New York, NY
- Advocacy and Relationship Management, Internal and External
- Ensures the proper management and training of all staff and assigned CRO personnel, Associate/ Clinical Research Specialists working on Edwards’ research programs
- Engages cross company expertise to develop, champion, and implement aligned biomarker strategies for development projects in support of the overall R&D portfolio goals
- Effectively engages with teams and governance bodies and utilizes advisory bodies to define, revise and progress translational/biomarker plans
- Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving toward delivering key data and interpretation essential for decision making on assigned enterprise level efforts
- Delivers high quality biomarker strategies for target engagement, pharmacodynamic endpoints and patient selection (where appropriate). Provide insight into novel ways to incorporate biomarkers into clinical designs
- Ensures the output of the biomarker plans meets established program standards (within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline progress without compromising quality
- Provides biomarker expertise to the Center of Excellence in Pharmacodiagnostics and partners to progress appropriate validated biomarkers into diagnostic development
Director Clinical Services
02/2012
-
04/2017
Houston, TX
- Engages functional area stakeholders to ensure alignment of biomarker strategies with clinical operational plans with functional area capabilities
- Plays a primary role in identifying key opinion leader(s)/principle investigators for the program to ensure adequacy of the program’s scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy
- Manage CTDS Steering Committee of senior cross-functional leaders
- Lead the Vertex CTDS Program Office and facilitate regular interactions with Vertex Product Teams, supporting and providing counsel and oversight of CTDS activities around product-specific submissions
- Ensure Vertex awareness and compliance with global CTDS requirements, including EMA Policy 0070 and US 42 CFR 11
- Develop training on ‘best practice’/lessons learned across geographies/product teams
- Develop SOPs for standardizing internal processes across geographies/functions
Director Clinical Quality
07/2009
-
12/2011
Chicago, IL
- Marshall existing and new resources in support of CTDS
- Develop and report metrics for tracking organizational activity
- Coordinate communications internal/external related to CTDS
- Develop and maintain intranet presence for Vertex CTDS
- Identify and build relationships with external experts and vendors, where appropriate, to gather intelligence and provide ‘benchmarking’ for Vertex CTDS compared with industry standards
- Represent Vertex interest in discussions with Health Authorities, global trade associations, consortia and other stakeholders in the evolving policy on this topic
- Primary responsibility is to lead the CROs and collaborations on Akebia’s pipeline
Education
Indiana Wesleyan University - Kokomo Campus
2003 - 2008
Bachelor's Degree in Nursing
Professional Skills
- Monitors concurrent clarification process to ensure appropriateness, format is compliant with AHIMA guidelines, and following JATA best practice guidelines. Reviews data for physician trends and possible education opportunities. Reports trended data to leadership and Revenue Leadership council or designated hospital committees
- Monitors and follows the established escalation process for outstanding chart clarifications. Escalates cases to physician advisor, CMO and CDI Director in a timely fashion
- Collaboratively works with Coding leadership team to ensure strong inclusive relationship and appropriate documentation is available in the electronic health record and Coding system as appropriate for outstanding clarifications. Ensure we fully support and take responsibility for communicating clearly to limit CDI holds for DNFB
- Provides ongoing education and training to new and current CDI team members to ensure appropriate onboarding and education has been done. Reports training status and quality rates to CDI Director on a monthly basis
- Develops and maintains realistic and innovative performance and clarification goals individually, and for team members, providing ongoing reports to Leadership and Senior Leadership, identifying concerns, achievements, and action plans as needed on a regular basis. Holds self and others accountable for individual and team goals set
- Demonstrated success in using oral and written skills, to effectively manage key stakeholders
- Management experience; effectively lead staff to meet departmental and organizational goals; good management skills, preferably in a marketing field
How to write Director, Clinical Resume
Director, Clinical role is responsible for clinical, leadership, analytical, interpersonal, direct, organizational, presentation, positive, health, organization.
To write great resume for director, clinical job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, Clinical Resume
The section contact information is important in your director, clinical resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Director, Clinical Resume
The section work experience is an essential part of your director, clinical resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, clinical responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, clinical position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, Clinical resume experience can include:
- Ensure that key goals for each alliance is achieved by the partners, oversee Akebia’s contractual obligations, and be the go-to person internally and for our partners for alliance-related matters
- Provide clinical research strategies, evidence development plans and study design and protocol development with cross-functional teams including Marketing, Health Economics, Regulatory and R&D
- Excellent communication skills including public speaking skills and written skills (reports, grant applications)
- Proven management skills with the ability to prioritize multiple projects and serve as an effective QA advocate
- Demonstrates excellent organizational, problem solving, decision making and communication skills
- Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions
Education on a Director, Clinical Resume
Make sure to make education a priority on your director, clinical resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, clinical experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Director, Clinical Resume
When listing skills on your director, clinical resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical director, clinical skills:
- Proven project management skills, excellent written and verbal communication skills
- Scientific writing skills and good communication skills
- Proven leadership experiences (people and project) including team facilitation skills and strong collaborative communications in a matrix organization
- Strong project management skills with proven experience in meeting timelines and clinical study expectations
- Demonstrates strong critical thinking skills, diplomacy, and relationship building
- Demonstrated process improvement skills/experience
List of Typical Experience For a Director, Clinical Resume
1
Experience For Director, Clinical Affairs Resume
- Strong facilitation and complex problem-solving skills
- Demonstrated knowledge of and skill in the following: adaptability, change, problem solving, customer service, oral and written communication
- Proven experience in medical writing is essential
- Advanced computer skills (word processing, spreadsheets, graphics, PowerPoint)
- Experience in a clinical laboratory, including both technical and administrative experience in areas of expertise
- Significant experience working with emerging healthcare delivery models, particularly in value-based care
- Negotiate situations involving competing priorities from multiple stakeholders
2
Experience For Director Clinical Services Resume
- At least three years’ experience working in an outpatient clinical setting
- Experience applying knowledge of data management, data review and analysis, and safety surveillance/reporting
- Models leadership by working collaboratively, providing appropriate advice and counsel to others to improve effectiveness and national performance
- Serve as group leader with new product development and marketing leaders to set priorities
- Previous experience as a Director of Nursing or senior level administration
- Builds strong relationships with key stakeholder and vendors including oversight of governance structures with vendors
3
Experience For Director, Clinical Services Resume
- Operate inside a matrix organization, sales, operations, product, pricing etc
- Experience in designing I&I Clinical trial strategies to obtain regulatory approval
- Experience applying knowledge of clinical medical device standards, FDA Code of Federal Regulations, GCP/ICH guidelines, and regulatory compliance
- Experience working directly with Medicare Stars or HEDIS, Risk- quality programs
- Experience managing team (10+)
- Demonstrated to initiative with commitment and ability to work under pressure and meet tight deadlines
- General managed care experience
- Strong detail orientation, organization, and management of multiple parallel projects with fluid timelines.
- Prioritize areas of business risk and incorporate into the strategy of quality improvement plan
4
Experience For Director Clinical Quality Resume
- Ensures continuity of care through the development of strong collaborative relationships with other agencies, providers and policy makers
- Extensive experience in the management of CRO/Vendor and site audits from within the Clinical Operations environment
- Understanding of I&I drug development process and the complexities of integrated drug development
- Understanding of value-based care and reimbursement models
- Training in performance improvement tools and techniques
- Training in change management, team dynamics and facilitation
5
Experience For Director Clinical R&D Lead Resume
- Understanding the global competitive environment for clinical project execution
- Understanding of I&I drug development process
- Leading Technology Upgrades
- Achieving desired outcomes within established time and budget perimeters
- Provides direct clinical and administrative supervision for clinical staff; responsible for interviewing, hiring, orienting, training and evaluating staff
- Managing people; including coaching, mentoring, and/or training staff
- Accountable for successful execution of all stages of EVLP program, including feasibility, start-up, conduct, close-out, reporting, archiving, etc
- Provide study oversight, including data monitoring (flow of data from sites, CRF completion, ensuring data entry in database, data listings, etc.)
6
Experience For Associate Director Clinical Quality Resume
- Responsible for supervising Programmers by planning/assigning workload
- Provides input and approval of staff training modules; provides training
- With the Training Director, develops plans and protocols for new clinical and program staff training and supervision
- Participates in care delivery for patients as needed including conducting admissions, recertification visits, routine visits, and discharge visits
- Incredible insight into how healthcare delivery is changing and a deep understanding of how data is needed to support new models of care delivery
- Directs the Infection Control Committee and functions including staff training and Patient/Employee Infection Surveillance and the infection risk analysis
- Provides input as necessary into planning of clinical programs, including vendor budgets/timelines
- Leads by example and mentors other team members, including employee development through company goal setting, performance management processes
7
Experience For Associate Director, Clinical Programming Resume
- Responsible for implementing and coordinating practice performance improvement plans. (10%)
- Implement and monitor the status of all clinical operations of BHOCS, providing feedback to stakeholders and making adjustments to workflows as needed
- Provide executive level updates regarding the status of BHOCS clinical operations including identified recommendations for changes to the current model
- Ensure compliance with all licensing agencies and accrediting organizations
- Be accountable for safety across relevant studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues
- Develop Therapeutic Area programming strategy and collaborate with other functions in regards to programming deliverables e.g. database design,
- Prepares, reviews and approves activity, resource, and progress reports regarding the clinical programming group for upper management review
8
Experience For Assistant Director, Clinical Pharmacokinetics Resume
- Provides on-going mentoring and guidance to CRA’s/CTAs
- Examples of applying innovative statistical thinking
- Provide data for dissemination to meet the needs for market registrations, reimbursement clinical and product marketing and further device development
- Assist in writing of scientific abstracts, presentations for international conferences and/or publications in scientific journals where appropriate
- Enhance existing supply chain solutions as assigned
- Establishes long-range operating plans, budgets and programs within the Department of Clinical Excellence
9
Experience For Director, Clinical Trial Management Resume
- Direct and provide oversight of performance improvement activities including both quality of care and service
- Provides oversight and consultative supervision of all non-medical direct care staff, including both administrative and clinical supervision within the CABHA
- Manages assigned supervisory and non-supervisory staff representing the S3 Division
- Promotes positive working relationship with family, physician, and other facilities
- Oversees the communication with the attending physician to ensure continuity and quality of care
- Makes marketing visits and provides in-services to all referral sources, as appropriate
- Define Flatiron’s strategy for supporting practices with clinical transformation, and execute on it
- Oversees the Clinical Informatics functions including compliant and meaningful clinical documentation and use of the EMR
10
Experience For Director Clinical Systems Resume
- Responsible for Affilia’s state licensure and accreditation survey readiness and ongoing compliance with regulation and standards
- Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations
- Responsible for directly supervising up to 30 Colleagues
- Travel to patient homes and nursing facilities within the local community
- Promotes and ensures professional practice and continuing education throughout the practice sites locations. (10%)
- Facilitates proper documentation to support all aspects of billing and cost containment issues. (5%)
List of Typical Skills For a Director, Clinical Resume
1
Skills For Director, Clinical Affairs Resume
- Strong communication skills, ability to prioritize, skills in project management
- Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills
- Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach with significant management experience
- Proven negotiation, collaboration, interpersonal, problem solving and conflict resolution skills
- Leadership skills and supervisory experience, including the ability to drive team performance
- Excellent communication and customer services skills necessary
- Proficient in Microsoft Word, Outlook, PowerPoint and strong Excel and analytical skills
- Effective communications (verbal & written) and presentation skills are essential
- Advanced negotiation skills and vendor selection experience
2
Skills For Director Clinical Services Resume
- Excellent organizational skills, especially when coordinating big projects, committees, and special events, like CEU, CME
- Effective communication skills via verbal, written and presentation abilities
- Strong project management, cross-functional team leadership and organizational skills
- Analytical skills with a data driven approach to planning, executing, and problem solving
- Five (5) years’ experience with continuous quality improvement processes including project planning and managing multiple priorities
- Demonstrated ability/experience with "influencing without authority"
3
Skills For Director, Clinical Services Resume
- Four or more years of clinical social work experience and two or more years supervisory/management experience required preferably in a hospital setting
- Advanced investigation and problem solving skills is required
- Demonstrated ability to successfully manage multiple projects with competing priorities to achieve the goals of the department and the larger organization
- Demonstrated experience leading projects, tasks, or staff required
- Demonstrated aptitude for process and technology; experience with process and training design and implementation
- Proven record of strong strategic thinking capabilities
4
Skills For Director Clinical Quality Resume
- Advanced organizational skills including use of Microsoft Project
- Prior experience managing remote teammates
- Demonstrated experience developing/implementing strategic sourcing
- Demonstrated effectiveness in resolving complex study and program management issues including vendor related performance management
- Work effectively with a wide group of people from R&D, software, legal, regulatory, marketing, sales, key customers, investigators etc
- In-depth knowledge/experience in GCP auditing activities and evidence of monitoring compliance with SOPs, GCP, and FDA
- Strong behavioral health clinical knowledge base including protocols for evidence-based care for mental health and substance use disorder
5
Skills For Director Clinical R&D Lead Resume
- Solid experience with SAS programming
- Demonstrated ability to work independently and manage complex projects with multiple priorities in a fast paced, team-based environment
- Demonstrated experience in leadership within a matrix team environment
- Eight years of progressively responsible experience in healthcare with two years of leadership experience required
- Progressive clinical, educational, administrative experiences which demonstrates success and credibility in nursing
- Demonstrated performance improvement experience
- Evaluates proposed projects and forms recommendations utilizing both clinical and analytical skills
- Nursing License in good standing
- Demonstrated track record of selecting and developing talented people indicating the ability to build/develop a high performing team
6
Skills For Associate Director Clinical Quality Resume
- Knowledge and experience in developing and implementing innovative new programs and in driving performance improvement initiatives
- Responsible for ensuring high quality data through data profiling, testing, validation and user acceptance
- Experience of 3 years or more in planning, developing and evaluating clinical simulation/SP programs
- Demonstrated expertise in leading, motivation and integrating project teams
- Experience in an inpatient acute care CDI management position dealing directly with physicians, nursing and ancillary departments
- Proven ability to establish operating guidelines and procedures, preferably in a global setting
- Experience in preparing for and leading accreditation surveys required
7
Skills For Associate Director, Clinical Programming Resume
- Experience of working with, and co-ordinating the work of CROs
- Effective collaboration across functions, resolving issues with minimal supervision, while understanding when to escalate
- Experience managing or leading staff
- Experience providing input / involvement in business strategy planning and development
- Pharmacist license in good standing and maintenance of continuing education credits
- Current and strong working knowledge interpretation/implementation of the Code of Federal Regulations and ICH Guidelines governing clinical trials
- Perform functional management review of major deliverables and supports individuals in providing excellent clinical
8
Skills For Assistant Director, Clinical Pharmacokinetics Resume
- Results driven leader with five years’ experience leading population health strategies in Medicare and Commercial populations
- Demonstrated knowledge of clinical operations, inclusive of data management, site monitoring/management
- Five years of more direct health plan and/or medical group quality management experience, including NCQA required
- Experience in insurance and Medicare/Medicaid billing and reimbursement desired
- Experience in clinical development, as well as an understanding of GCP and GCLP, required
9
Skills For Director, Clinical Trial Management Resume
- Participate in the definition and prioritization of sample tracking system requirements, enhancements, and process improvement for user communities
- Experience supporting clinical transformation initiatives within the Accountable Care Organization (ACO) space
- Front facing provider experience
- Strong analytic thinking capabilities
- Leadership experience in a health care setting- preferably in a managed care organization or provider practice
- Eight or more years of managerial experience in an informatics role including computer system implementation, support and maintenance
- Experience and expertise in posting clinical trial information and data on regulatory agency public registries
- Experience as an RN, preferably in acute care setting
10
Skills For Director Clinical Systems Resume
- Experience facilitating CDI teams/role as a change agent required
- Experience in teaching and instruction required
- Consults with nursing leaders, Performance Services and other departments in the development of effective data collection and analysis
- Facilitates effective communication between study sites and study team members to ensure on-going successful execution
- Experience in all facets of work as a counseling center mental health professional
- Maine – RN with 1 year of experience and training in hospice care
List of Typical Responsibilities For a Director, Clinical Resume
1
Responsibilities For Director, Clinical Affairs Resume
- Builds Human Capital: Identifies, selects, and retains Humana’s diverse talent, capitalizing on associates’ competencies, ideas and passion. Aligns talent with key components of our business strategy to create value for all stakeholders. Assesses, develops and rewards talent, encouraging progression throughout the enterprise
- Motivate and inspire associates to higher levels of engagement, productivity and personal achievement. Provides regular, timely guidance/feedback to encourage developmental opportunities for associates, both direct and indirect reports
- Accountable for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations,
- A PhD in Statistics or related field with at least 6 years of relevant clinical trials experience, or a Master’s in Statistics or related field with 8 years of experience is required
- Works with the global FCS GM’s, Fisher BioServices, PSI and other Thermo Fisher Scientific units to collaborate on the over-all CAM strategy and solutions that best meet the client’s needs
- Experience in working with the FDA and its regulations
- Strong understanding of Clinical Evaluation Report (CER) requirements
2
Responsibilities For Director Clinical Services Resume
- Excellent working knowledge of CDISC standards (CDASH and SDTM) and CDM Best Practices
- Experience in leading an integrated and progressive quality organization, preferably within health care industry
- Demonstrates and promotes the company and Division’s mission and vision
- Being an Advocate for the 5 Highly Reliable Organization (HRO) Principles
- Provide clinical and administrative leadership by directing, delegating, supporting, coaching, empowering, educating and role modeling
- Develops, maintains and facilitates the tools used in Nursing and Patient Care Services for collecting and reporting of data
- Successfully dealing with and managing Philips relationships with regulatory such as notified bodies & the US Federal Drug Administration (FDA)
- Assist with training/ mentoring of junior staff, as applicable
- Participates in internal staff meeting and training activities, as assigned
3
Responsibilities For Director, Clinical Services Resume
- Managing and mentoring individual contributors
- Designs and develops specific databases for collection, tracking and reporting data
- Review availability of sufficiently qualified vendor resources on a regular basis, contributes to planning of future vendor resource needs
- Manage training program of vendor staff in AIRM/Astellas standards, processes, and systems
- Supervises the licensed clinical staff including but not limited to OT, PT, SLP, TR, Behavior Analyst, Psychologists, Social Workers, etc
- Collaborates with professionals providing psychological services to participants to ensure coordination of care
- Responsible for establishing policies and procedures related to patient care. (20%)
- Establish and execute high quality, integrated cross-functional project plan for the EVLP program to deliver study milestones according to plan
4
Responsibilities For Director Clinical Quality Resume
- Oversee and organize study meetings as applicable; ensure meeting minutes are finalized and filed
- Responsible for implementing the operational plan within the EVLP development team
- Line management responsibilities for direct reports (e.g., goal setting, performance evaluation, professional development, etc.)
- Develop and maintain Project Plan including risk mitigation and quality control as appropriate
- Oversee the writing of key program-related/study-related documents (INDs, protocols, abstracts, presentations, CSRs, regulatory responses, NDAs) and SOPs
- Oversee development of annual/ quarterly goals, monitor ongoing performance and identify areas to strengthen as appropriate
- Ensure screening and evaluation of potential Investigators to ensure compliance with regulatory and corporate requirements
- Participates and supports efforts towards nursing shared governance and staff development
- Management and fiscal accountability for reporting departments
5
Responsibilities For Director Clinical R&D Lead Resume
- Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
- Oversees staff responsible for providing support to end users of the agency’s clinical software applications
- Ensures that support documentation exists, including procedural documentation for use of applications and problem resolution
- Involves third parties if appropriate in solving clinical application-related issues
- Identifies strategies for meeting financial objectives for his/her department
- Responsible for the appropriate use of agency resources including but not limited to supplies and personnel to ensure financial success
- Maintains availability at all times during his/her scheduled hours of work, either in person or by telecommunications
- Develop patient recruitment strategies including
- Maintains an overview of development trends within the industry relating to new clinical service opportunities
6
Responsibilities For Associate Director Clinical Quality Resume
- Responsible for oversight of clinical decision-making aspects of the clinical program
- Directs utilization management and case management programs in the development of clinical programming to improve the health outcomes
- Collaboratively participate and oversee the development, implementation and interpretation operating policies, procedures, and performance standards
- Responsible for driving the organization to achieve and surpass sales, profitability, business goals and objectives
- Responsible for directing human clinical trials, phases I – IV, for company products under development
7
Responsibilities For Associate Director, Clinical Programming Resume
- Provide on-going assessment and interventions with staff, systems, and processes, based on identified clinical and administrative needs
- Monitor particular clinical and administrative functions, requiring a high level of professional, leadership and strategic expertise
- Manage clinical programming timelines to coordinate and synchronize deliverables with overall study timelines/milestones
- Lead the formulation of clinical development plans, including selection of the proof of concept indications for specific projects
- Participate in the development and delivery of protocol training for investigator site and FivePrime staff
- Oncology fellowship training and active board certification within the last 5 years
8
Responsibilities For Assistant Director, Clinical Pharmacokinetics Resume
- Flexibility to work with colleagues in a matrixed setting
- Stay current with industry best practices to develop and lead strategic and operating plans. Oversee the development and execution of these plans
- Provides overall management for all internal Nursing and Patient Care Services EBP and Clinical Excellence databases
- Determine annual metrics in conjunction with DUHS Nursing leaders
- Conducts data reporting and statistical analysis activities.
- Develops innovative, realist solutions to support the Duke Health and DUHS Nursing Strategic Plan
- Leverage networks to achieve influence with others and represent programming in cross functional forums to determine the best course of action
9
Responsibilities For Director, Clinical Trial Management Resume
- Expert at leveraging limited resources for maximum impact on projects and initiatives
- Monitor and forecast programming resource needs and ensure that projects are sufficiently resourced
- Participate in Project/Study Team meetings as needed to provide programming expertise and creative solutions to problems
- Oversees global clinical programming operations. Assigns geographic regions to subordinate management
- Liaises with Human Resources department for recruitment strategies and resource forecasting
- Develops and/or approves training materials and ensures delivery
- Able to rapidly respond to shifts in regulatory and accreditation requirements or emerging science through a nimble adaptive management style
10
Responsibilities For Director Clinical Systems Resume
- PA RN Nursing License, ARRT, ARDMS, NMTCB, or equivalent clinical or technical certification
- In-depth understanding of clinic operations and the roles of direct caregivers in mission accomplishment
- A successful history of implementing the electronic health record, clinical documentation, and computerized physician order entry
- Co-lead the development of a repeatable standard process for care model design and piloting in order to create rigor and discipline across organization
- Specific training related to behavioral health services
- Three (3) - Five (5) years of increasing responsibility in leadership/oversight of Quality programs
- A working knowledge of GCP and ICH
- Able to complete physical management training and perform physical management techniques
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