Senior Clinical Resume Sample
Leonor Cummings
3880 Champlin Island,
Boston,
MA
+1 (555) 435 2349
Work Experience
Senior Clinical Affairs Specialist
02/2017
-
PRESENT
Dallas, TX
- Recent hematology/oncology experience
- Responsible for outreach efforts based on registries and other tools to help close patient care gaps, facilitate referrals, and other services as needed to promote highest quality of care, and optimum health
- Oversees the department’s research activities
- Faculty member for OGD &GMA and OTM training programs, author or reviewer for clinical SOPs
- Supports inspection readiness for GCDO through periodic quality assessment of clinical records
- With direction from the CDM Lead, prepares clinical records for agency inspection
- Manages assigned TMF corrective action plans under direction of CDM Lead
- Acts as mentor for CDM, providing training and support around clinical document management activities
- Supports CDM led initiatives to enhance efficiencies in document management
Senior Clinical Program Leader
09/2011
-
12/2016
Phoenix, AZ
- Provides clinical consultation and support to internal teams involved in product development, ensuring that clients’ needs are accurately represented in product planning cycles
- Develops Case Studies and whitepapers that describe the business case or ‘return on investment’ that Patient Flow brings SH customers and to the broader marketplace
- Ability and willingness to learn new tools and Healthcare Information Systems (HIS) to be identified as part of RIC’s future core applications toolset. Example technologies include new Cerner modules
- Travel required: 10-30% in support of clinic audits and vendor/supplier audits
- HUMAN RESOURCE MANAGEMENT: Effectively performs personnel task , recruitment, counseling, and disciplining staff as appropriate. Ensures appropriate staffing and compliance with institutional-wide and department policies. Effectively mentor staff to maximize skills, knowledge and abilities
- FINANCIAL MANAGEMENT: Makes continuous efforts to ensure cost effective , efficient operations. Develops annual budget and financial analysis
- QUALITY MANAGEMENT: Quantify department efficiency and effectiveness through benchmarks and continuous quality improvement methods. Develop and oversee departmental patient satisfaction and customer service programs
- EDUCATIONAL/ PROFESSIONAL DEVELOPMENT: Serves as a mentor to, and promotes professional development of staff. Ensures personal professional growth and development
- DEPARTMENTAL SPECIFIC RESPONSIBILITIES: Accountable to Department Chair for all operations. educational and research initiatives. Management of Department Contract. Collaborated with Department Chair on all strategic initiatives
Senior Clinical Engineer
07/2008
-
07/2011
Chicago, IL
- Oversees hiring, placement and training for technicians and other staff within the HCT business department, while maintaining a strong focus on retention and team development
- Implements human resources policies and procedures, including regular performance reviews and effective performance management, in a corporately responsible manner
- Responsible for ensuring all employees are adhering to the Global Code of Conduct and employee’s behaviors coincide with values and mission of Aramark
- Communicates, through the proper chain of command, critical information and decisions as appropriate, and responds to requests from District Manager, Regional VP, and Corporate Staff
- Represents Clinical Affairs on project/core teams, providing clinical input on Product Development and Clinical Research teams
- Responsible for writing and maintaining clinical deliverables for the AF Solutions portfolio of products
- Collaborate (writing, reviewing, editing, approval) with clinical, R&D, quality, and regulatory teams on clinical documents, and other documents that require the evaluation of clinical data and/or clinical literature
- Performs review and analysis of evidence gaps in the cardiac ablation, mapping and navigation space
- Develop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written report
Education
University of Phoenix - Colorado Campus
2002 - 2007
Bachelor's Degree in Nursing
Professional Skills
- Demonstrated experience leading groups and strong presentation skills
- Excellent written and verbal communication skills including public speaking and web based training/education experience
- Demonstrates strong problem solving, creativity and critical thinking skills to accomplish objectives
- Strong working knowledge of application support, development tools, and methodologies. Demonstrates good communication skills
- Strong attention to details with excellent written and verbal communication skills
- Demonstrated skills in technical writing, presentation, and teaching
- Experience analyzing data using SQL, with demonstrable skills
How to write Senior Clinical Resume
Senior Clinical role is responsible for interpersonal, analytical, organization, research, presentation, clinical, planning, training, development, engineering.
To write great resume for senior clinical job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Clinical Resume
The section contact information is important in your senior 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 Senior Clinical Resume
The section work experience is an essential part of your senior 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 senior 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 senior clinical position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Clinical resume experience can include:
- Constructive interpersonal skills that include effective written and verbal communication skills with all stakeholders
- Significant direct line management experience as well as demonstrated leadership, influencing, communication and strategic project management skills
- Solid PC skills, specifically using MS Word, Outlook, Powerpoint and Excel
- Excellent communication skills in English– both spoken and written
- Strong communication, presentation and interpersonal skills with high level of attention to detail, accuracy and organization
- Strong computer skills in a EHR systems in use
Education on a Senior Clinical Resume
Make sure to make education a priority on your senior clinical resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior 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 Senior Clinical Resume
When listing skills on your senior 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 senior clinical skills:
- Demonstrates good planning and organizational skills
- Excellent written and oral communication, interpersonal and problem solving skills
- A combination of strong analytical and problem-solving skills
- Proven ability in effectively communicating analytics requirements and solutions to others
- Skilled in the use of MS Office, in particular PowerPoint and Advanced Excel Skills (essential)
- Experience of APEX, VBA, SQL and SharePoint skills all desirable
List of Typical Experience For a Senior Clinical Resume
1
Experience For Senior Clinical Affairs Specialist Resume
- Very good organizational skills, analytical understanding, and a goal- as well as team-oriented working style
- Demonstrates a good understanding of the requirements of the study design, conduct, analysis and report writing for regulatory submissions
- Display stakeholder management skills (e.g. ability to manage expectations)
- Work autonomously, to efficiently and effectively provide status reports
- Experience: 5-7 years relevant experience
2
Experience For Senior Clinical Program Leader Resume
- Consults and provides input into system validation efforts including tool maintenance activities
- Cardiovascular physiology and/or cardiac arrhythmias experience
- Adept at solving complex problems in creative and effective ways
- Excellent team player with an analytic, proactive, goal-oriented attitude
- Regulatory experience highly desirable
3
Experience For Senior Clinical Applications Analyst Resume
- Accountable to the Clinical Evidence Manager for performance
- Handle multiple tasks, prioritize his/ her activities and to drive the team accordingly
- Scheduling meetings, taking notes of meetings, preparing following up lists
- Traveling to CMO’s for operations and audits as needed
- Anticipating needs of the senior team
- Preparing drafts of presentations/decks
- Serving on or leading appropriate SRAlab committees
4
Experience For Senior Clinical Engineer Resume
- Troubleshooting, and problem correction. (35%)
- Understanding of software development and ability to quickly adapt to changing requirements
- Assists with scheduling, coaching, training, hiring, counseling and performance assessments
- Performs as a role model and positive influence, identifying and facilitating changes by promoting staff competence and understanding of issues
- Accountable for planning and executing state-of-the-art clinical pharmacology program with direct value on specific projects including go/no go decision making
- Provide support to Study Teams throughout Clinical Trial lifecycle, including driving site engagement, troubleshooting, and escalation
- Responsible for following and maintaining accreditation readiness for OR neuromonitoring and certification as applicable
- Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post-marketing commitments
- Maintain a running matrix of clinical marketing support/needs for each product unit for communication purposes
5
Experience For Senior Clinical Data Prgrming Lead Resume
- Work with Director, clinical marketing, to develop and brand clinical marketing function within Structural Heart
- Establish and maintain living labs for testing prototype devices
- Coordinate labeling and final packaging operations at CMO’s
- Inventory management including retest update tracking
- Develop and maintain an optimized study planning with other functions (including identification of critical path)
- Coordinate multiples interfaces: Complex studies including several vendors, external non-standard data (e.g. Complex biomarkers, imaging, etc.)
- Manages data analysis from business and pharmacy perspective to support customer contract reporting needs and financial modeling needs
6
Experience For Senior Clinical Innovation Manager Resume
- Assist with maintaining files, copying and mass mailings
- Assist study coordinators with filing and archiving as needed
- Ensures reliable reports (including enrollment graphs) of patient/study status and screening metrics are provided to Leadership weekly
- Utilize a high level of problem solving and critical thinking to support ACOs in population health and achieve shared goals
- Be familiar with the travel booking system, expense reporting
- Provides technical guidance, training and mentoring to technical / non-technical personnel
- As a Sr. Site Monitor, serves as the example of professionalism, collaboration and efficient execution of deliverables, including mentoring others
- Acts as Clinical Information Standards (CIS) project manager for selected standards / coding projects
- Works with team members via matrix relationships in standards and coding implementation and optimal usage in clinical trials
7
Experience For Senior Clinical Trial Operations Manager Resume
- Highly motivated, outgoing, creative and open minded personality
- Collaborate with Director of Early Innovation to plan clinical budget and pay invoices from strategic partners and/or living labs
- Analyze large scale Genomics and Biomarker data (e.g. DNA sequencing incl. variation and methylation analyses, microbiomics, GWAS, transcriptomics)
- Participate in Interactive Response Technologies(IRT) including (IWRS/IVRS)) specification design, implementation and support
- Participate in the training of new CTOMs on therapeutic area and general responsibilities within their function
- Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot
- Cross-functional leadership fostering team spirit and team motivation (team work), e.g. study team or transversal project team
- Facilitates decision making and adoption based on industry best practices
8
Experience For Senior Clinical Workflow Consultant Resume
- Coordinates the unit, functional, and integrated testing for assigned application
- Handles troubleshooting and manages multiple projects
- Troubleshoot and solve study build and edit chec programming issues
- Ensure quality by providing senior review of study deliverables
- Coordinate all technical aspects of the collaboration, including
9
Experience For Senior Clinical Product Manager Resume
- Develop short and long term clinical strategies to position Illumina as a leading clinical company in the assigned territory
- Provides continuous communication to in-house clinical trial leaders regarding the status and performance of multiple studies
- Strategic account management by partnering with key site personnel to drive continuous improvement across all aspects of clinical trial execution
- Serve as a key influencer for cross-SBU and CRI site engagement according to the agreed CVG CRI governance structure
- Jointly accountable with the pharmacometrician for providing a scientific justification for the dose selection
- Contribute to internal initiatives to develop the clinical pharmacology discipline including its processes
10
Experience For Senior Clinical Pharmacokineticist Resume
- Participation in and accountability for peer review of ongoing activities, reports and presentations
- Provides input and direction to project teams in order to arrive at a sound clinical evaluation
- Ability and willingness to learn new tools and Healthcare Information Systems (HIS) to be identified as part of SRAlab's future core applications toolset. Example technologies include new Cerner modules
- Ability and willingness to learn new tools and Healthcare Information Systems (HIS) to be identified as part of SRAlab’s future core applications toolset. Example technologies include new Cerner modules
- Communicate the product business plan to the clinical evidence generation group to support development of all clinical-related strategies and plans
- Collaborate with product managers and sales represent to get regular pulse on the field needs and develop strategies to counter/resolve
- Identify gaps and put solutions in place
List of Typical Skills For a Senior Clinical Resume
1
Skills For Senior Clinical Affairs Specialist Resume
- Proven interpersonal skills as well as strong oral and written communication skills
- Excellent organisational and communication skills, analytical understanding, and a goal- as well as team-oriented working style
- Effectively prioritizes time in order to meet deadlines, goals, and action
- Organization & problem-solving skills
- Experience in clinical and drug development, including 5+ years of clinical trial management experience
- Creative problem solving skills.
2
Skills For Senior Clinical Program Leader Resume
- Communicates effectively in verbal presentations and in writing technical reports
- Advanced skills in management of clinical or related engineering projects
- Clinical experience in critical care or med-surgical experience required
- Excellent knowledge of and working experience with various software packages such as Microsoft PowerPoint, Excel, Word, Project, etc
- Effectively translate complex business requirements to functional requirements
- Able to effectively communicate informatics and point-of-care technology initiatives and data to a range of audiences
3
Skills For Senior Clinical Applications Analyst Resume
- Written and oral communication skills is required
- Prior technical or medical experience in neuromodulation
- International clinical development experience and working abroad experience desirable
- Experience with development, validation, execution, maintenance of Clinical Applications is required
- At least five years direct oncology experience in Phase l – lll in solid and liquid tumor types
- EU/APAC: Prior relevant experience in building study databases
- Medical device industry experience or similar industry experience
4
Skills For Senior Clinical Engineer Resume
- Prioritizing activities based on the needs of the business
- Training and experience with PK software (Phoenix, WinNonlin)
- Experience using Microsoft Excel to create spreadsheets including editing, filtering, and manipulating data
- Leads unit and integrated testing of the software to ensure that the design objectives are met, including the development and validation of testing scripts
- Experience planning and executing internet literature searches using databases such as PubMed
- Strong level of computer literacy and use of word processing, spreadsheets, databases, graphics, statistics, engineering tools and programming
- Demonstrated ability to apply an expert understanding of clinical applications to issues in order to bring tasks to resolution within assigned projects
- Experienced in working and documenting in multiple electronic platforms
- Experience working to analyze data and bring forward recommendations to leadership and other stake holders to influence improved care
5
Skills For Senior Clinical Data Prgrming Lead Resume
- Experience with meeting set up and event planning
- Medical writing and/or scientific writing experience within a medical device or related industry
- Collaborate with the Clinical Supplies Platform to validate IMP needs, specifications, packaging, shipment (including resupply) and reconciliation process
- Demonstrated ability to act as Lead CTOM, leading the study team and being able to efficiently work with other CTOM’s in the same study
- Experience in managing and leading international meetings (e.g. Study Teams)
- Good understanding of US FDA advertising /promotional regulations
- Experience in leading the gathering and documentation of requirements
6
Skills For Senior Clinical Innovation Manager Resume
- Guides other team members in ensuring good documentation standards
- Experience with statistical analysis software (e.g. R, SAS, etc.) and scientific graphing and analysis software (Sigma plot, GraphPad, etc.)
- Proven ability to provide performance management coaching and staff development
- Proven ability to implement and manage a clinical program (i.e. a series of studies compromising a clinical development plan)
- Experience working with Quosa, Endnote or other literature repository and citation management tools
- Experience in one or a combination of: Health Coaching/Case Management/Utilization Management and development and implementation of educational programs
7
Skills For Senior Clinical Trial Operations Manager Resume
- 6+ months of experience working within the Healthcare Industry
- Experience in Clinical Affairs in the medical device industry including both domestic and international
- Experience supervising CRO-driven studies
- Proven ability to conduct and analyze more complex clinical pharmacology studies using various PK/PD software programs
- Direct experience working with Medicare
- Healthcare Consulting or Health Plan/Payer experience
- Expert understanding, knowledge and experience of drug development across the value chain with particular focus on early development and clinical pharmacology
8
Skills For Senior Clinical Workflow Consultant Resume
- Experience in health plan provider network performance management, care/case management, provider relations, provider contracting, etc
- Previous population health management experience within an ambulatory setting
- Clinical research field monitoring and/or data management experience
- Good understanding of basic data manipulation techniques and data visualization concepts
- Review and edit product manuals, implementation procedures, and lessons learned during validation phase
- Ensures new processes adhere to regulatory requirements and provide thorough data capture for prompt, smooth, and effective processing
9
Skills For Senior Clinical Product Manager Resume
- Operates within the requirements of global SOPs and working instructions
- The ability to anticipate and proactively support the needs of the DCO and exercise judgment in prioritizing requests for their time
- Develop strong relationship with CRI sites and have a deep understanding of CRI site goals, personnel, processes, and capabilities
- Preference given to candidates with existing experience or familiarity with surgery/surgical technology
- Experience with managing small projects or work streams as part of a larger project
- Conduct prototype training & set up with intended users prior to clinical study initiation
- Knowledge and experience with HL7 Interfaces required
- Knowledge and experience with SQL based applications required
10
Skills For Senior Clinical Pharmacokineticist Resume
- Coordinates with Lead CISs and Standards Team Lead to prioritize and deliver standards related initiatives
- Extensive experience in data analysis, ideally with a known Business Intelligence platform, such as Spotfire (highly desirable)
- Extensive hands-on experience and detailed knowledge of PK software (e.g. WinNonlin, ADAPT II, Berkeley Madonna, NONMEM, etc.)
- Experience with cancer-related clinical data including diagnoses, medications and outcomes measures
- Hands on experiences of using statistical tools
- Experience in clinical affairs
- Demonstrate in-depth clinical knowledge, particularly in sleep and respiratory care
- Proficient in communication, with good grasp of English both oral and written
- Build and maintain effective relationships with Bayer Medical Dealers, and OEM’s as appropriate
List of Typical Responsibilities For a Senior Clinical Resume
1
Responsibilities For Senior Clinical Affairs Specialist Resume
- Assists with the maintenance of designated GCDO developed standards models (including but not limited to: SDTM, CDASH, Terminology, ADaM, TFLs, document templates, questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts
- Strong and effective communication skills are required in relating to customers and colleagues both inside and outside the organization
- Strong inter-personal relationship skills with ability to work in large and diverse teams
- Effective organizational, communication, and project team skills; high attention to detail and accuracy
- Demonstrated ability to effectively interact with internal and external stakeholders
- Demonstrated experience identifying problems, developing solutions, and executing to plan
2
Responsibilities For Senior Clinical Program Leader Resume
- Demonstrated experience in various therapeutic areas
- Conduct monitoring and/or co-monitoring visits as determined by project needs and previous experience and training as a CRA
- Actively participate in planning meetings to ensure the project needs, priorities and timing are understood
- Experience with launching new products into the clinical market is ideal
- Lead CRA experience which includes leading CRA's throughout Europe
- License in nursing with three (3) or more year’s clinical experience with vascular access devices
- Ability & experience to work in a fast-moving, self-driven team
- Experience with integration of clinical process improvement with physician / clinician workflow and thought-flow perferred
- Experience in clinical program management or a directly related role
3
Responsibilities For Senior Clinical Applications Analyst Resume
- Drive, encourage and support innovation. Demonstrated ability to challenge established practices and concepts
- Demonstrated ability to incorporate and adhere to regulatory standards
- Health care experience (health plan, managed care or provider based)
- Experience in Inflammation, Immunology and/or Infectious Disease
- Demonstrated pragmatism and willingness to drive and support change
- Proven ability to support innovation even if taken outside of his/her comfort zone
- CRHF therapies/technology experience
- Making revisions or providing feedback, as appropriate; messaging internal feedback in a clear and concise way
4
Responsibilities For Senior Clinical Engineer Resume
- Providing ongoing feedback and coaching
- Understanding of FDA regulations regarding medical device research and development
- Meeting materials prep, including creation of Optum Day packages and binders for in-person meetings
- Reviewing and analyzing clinical trial protocols, Informed Consent Forms, proposed study budgets and other trial documents to identify all items and services
- Identifying and providing CPT/HCPCS/APC/DRG codes to the relevant items and services
- Providing the draft CA for quality review or directly completing the QA review
- Aligning and directing clinician’s activities to support the needs and goals of the America’s US Hospital business
- Ensuring existing processes are followed to reduce variability
5
Responsibilities For Senior Clinical Data Prgrming Lead Resume
- Providing advanced clinical knowledge to assist in the selling process
- Working knowledge of the regulatory, legal and IT challenges associated with a growing pharmaceutical company
- Working knowledge of regulatory requirements such as GCP, ICH and HIPPA etc
- Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements
- Understanding of the clinical development process, and the role of non-R&D functions
- Fluent Chinese (writing/reading/speaking)
- Review monitoring reports and track ongoing site issues
6
Responsibilities For Senior Clinical Innovation Manager Resume
- Guide metabolic, co-dosing and drug-drug interaction issues, collaborating closely with cross functional colleagues
- Troubleshoot product issues during Beta testing and identify root cause
- Develops and maintains current access to expert knowledge of evolving and emerging medical technologies and provide consultation to clinicians and leadership
- Oversees and coordinates the daily operations of the Clinical Applications Analyst team, troubleshooting and resolving issues as they occur
- Develops novel client-reporting and non-client reporting methodologies and hands off to respective Business Analysts in other departments for their use
- Knowledge of reporting tools such as SQL Server Management Studio, Tableau, and other reporting software
- Work in a virtual team environment-accomplishing and coordinating work remotely
- Coordinates submission into Shire’s reporting database
- Strategize with study managers and review study protocols to determine appropriate packaging configurations and optimal distribution plans
7
Responsibilities For Senior Clinical Trial Operations Manager Resume
- Coordinate forecasting efforts to ensure the adequacy of the supply plan and negotiate resolution of resource conflicts where necessary
- Results reporting via interfaces to EMR’s on campus (EPIC, Meditech), and via our fax server for external clients
- Create and maintain clinical deliverables and plans (i.e., Visit Report and Letter Templates, Monitoring Plan, Recruitment Plan, etc.)
- Develop and conduct study team training
- Guide and/or assist with PK/PD modeling and simulations
- Travel approximately 10%, including international
- Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results
- Possess a understanding of the Agile development process
8
Responsibilities For Senior Clinical Workflow Consultant Resume
- Proficient in utilizing basic Microsoft office tools such as Excel, Word, Power Point, Visio and other tools
- High level of knowledge of electronic, mechanical or computer engineering design and applications principles
- Work as part of a team, while demonstrating ownership of assigned projects
- Organize and coordinate documentation related to IVD clinical studies being conducted in China both for China approval and globally
- Provide guidance for clinical pharmacology plans including drug-drug interaction, special population and safety studies
- Represent clinical pharmacology during face-to-face regulatory interactions, as appropriate
- Assist with modeling and simulation plans
- Ensures safe functioning of medical equipment in regulatory compliant environment of care
9
Responsibilities For Senior Clinical Product Manager Resume
- Manages medical device integration, interoperability, and networking
- Mentors and trains engineering and technical staff
- Plans, directs, and facilitates clinical content development efforts including order sets, clinical documentation templates, tools, and data dictionaries
- Ensures functions correctly, efficiently and thoroughly according to industry standard
- Delegates appropriately providing adequate direction and follow up
- Successful track record in planning, conduct and publication of Basic Science and/or Clinical Research
- Participates in the assessment, implementation, maintenance, integration and governance of systems and tools to support, manage, govern and report on standards
- Works with Lead CISs to ensure data management service providers have the appropriate knowledge, training and deployment of Shire’s standards within the service providers’ infrastructure
- Participates in a Standards Area Working Group/Team
10
Responsibilities For Senior Clinical Pharmacokineticist Resume
- Supports standards library, knowledge base/governance portal and other applications. Coordinates with IT where necessary
- Coordinates the generation and distribution of Lay Results
- Summaries for Patients to principal investigators
- Manages program in compliance with Aramark’s Quality Performance Quotient (QPQ) and the account scope of service per the contract
- 70%: Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of CDO ensuring effective life cycle management of the clinical section of the Trial Master File (TMF)
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