Clinical Scientist Resume Sample
Randy Mills
459 Isabel Court,
Houston,
TX
+1 (555) 712 7166
Work Experience
Senior Clinical Scientist
07/2017
-
PRESENT
Detroit, MI
- Provides scientific/clinical oversight for respective area of projects and collaborates with operational project managers and directors assigned to area programs. Consults with appropriate internal and external customers regarding the respective area’s clinical development, regulatory issues, and points of interest
- Communicates with CRA’s, Investigational Site Clinical Staff, and microbiology staff to support site selection, set-up, or study execution as needed
- Serves as the respective area’s Subject Matter Expert to ensure an appropriate level of understanding such that project teams consistently operate in compliance with sound research principles. Provides scientific oversight and program/product development training to Company staff and project teams
- Researches and makes recommendations on current regulatory requirements, as they pertain to microbiology, and industry practices related to the respective area’s product development in the US, Canada, Europe and other key markets
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and
- Collaborate with team members in the review and development of Data Management activities including development of eCRFs, edit checks, report development and database lock processes
- Participate in activities related to review of data review, database lock, medical monitoring and query resolution for the protocol
- Work with medical monitors and drug safety vendor(s) to provide support and scientific review of adverse events
Clinical Scientist
07/2012
-
06/2017
Dallas, TX
- Provide scientific review of statistical analysis plans
- Contributes to the clinical oversight and medical guidance in collaboration with the Principal Clinical Scientist, and (Senior) Global Clinical Program Director during the conduct of the study
- Contributes to multidisciplinary task forces to support continuous improvement (i.e. quality circles, SOP harmonization, ACE)
- Assist in the preparation and review of key regulatory documents, submissions, and annual reports. Present clinical performance data to FDA reviewers and other regulatory officials
- Support divisions with posting of protocols, study results and adverse events on ClinicalTrials.gov
- In a clinical research environment
- Contacts Inside the Company
- The Clinical Laboratory Scientist II is directly responsible to the Technical Manager and/or the Department Manager or delegate
Microbiology Clinical Scientist
02/2010
-
02/2012
New York, NY
- Responsible for supervising, delegating and coordinating the work of other staff as assigned
- Supervisory skills in areas of assuming responsibility, exercising independent judgment, making judicious decisions when responding to issues and problems and flexing staff to accommodate workload
- Strong English skills (verbal and written if English is the second language
- Oversee the trial master file (TMF) documents owned by serology in accordance with regulatory requirements and the Quality management system
- Ensure scientific and operational support for execution of activities within the CSO for study(ies) he/she is allocated to, under the functional supervision of the CSD and/or Medical Operations management
- For all new protocols, is in charge of assessing the protocol complexity, before and after protocol review, and after any protocol amendment
- Is involved in medical reviews of study data under the CSD supervision, supporting the CSD for the Medical Review cases and for review of safety events reported to GPE
- Support CSD for the preparation, organization and minutes of Study Committee meetings to include Steering Committee and Data Monitoring Committee
- Prepare the contracts for Study Committees in collaboration with business support
Education
Amberton University
2005 - 2010
Science's Degree in Science
Professional Skills
- Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
- Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in communicating a clear overview of trial results
- Excellent written and verbal communication skills; Demonstrated clear thinking & problemsolving
- Excellent written and verbal communication skills; Demonstrated clear thinking & problem-solving abilities
- Strong in business experience, solid marketing knowledge and skills
- Demonstrated oral and written communication and computer / database management skills
- Strong interpersonal and communication skills; proactive approach
How to write Clinical Scientist Resume
Clinical Scientist role is responsible for medical, clinical, english, research, development, analytical, scientific, reporting, database, languages.
To write great resume for clinical scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Scientist Resume
The section contact information is important in your clinical scientist 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 Clinical Scientist Resume
The section work experience is an essential part of your clinical scientist 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 clinical scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Scientist resume experience can include:
- Demonstrate strong oral, written and communication skills and a strong attention to details with the ability to multitask
- Good communication skills with product development, subjects, etc, and desire to work in a team environment
- Effective written, verbal and presentation skills in the area of technical/clinical applications
- Leadership skills, including motivating, delegating, coaching, and mentoring
- Extensive experience in drug development within the biopharmaceutical industry, including experience working on multi-functional global development teams
- Understanding of response evaluation criteria and staging systems for solid and liquid tumors is required
Education on a Clinical Scientist Resume
Make sure to make education a priority on your clinical scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical scientist 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 Clinical Scientist Resume
When listing skills on your clinical scientist 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 clinical scientist skills:
- Strong analytical skills (analyzing feasibilities studies and ways of working within hospitals)
- Good communication, interpersonal, negotiating and reporting skills
- Demonstrated/potential for critical thinking skills and sound decision-making
- Excellent analytical, experimental and independent problem-solving skills
- Excellent verbal and written English language skills; knowledge of Finnish is nice to have
- Strong clinical study experience in Oncology. Industry experience is preferential but an academic setting focused on clinical trials is applicable
List of Typical Experience For a Clinical Scientist Resume
1
Experience For Senior Clinical Scientist Resume
- Demonstrated effective oral and written communication skills and excellent interpersonal skills
- Excellent written and verbal communication skills; customer service skills
- Prior industry experience or clinical practice experience, preferably in a research/academic setting
- Effective verbal and written communication skills in relating to colleagues and associates at all levels both inside and outside the organization
- Good Medical writing skills
- Strong verbal communication skills required both for in-person and remote settings
2
Experience For Principle Clinical Scientist Resume
- Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings),
- Strong team collaboration, project management, leadership, communication (written and verbal), issue identification and resolution skills
- Demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
- Prior experience in supporting development of systemic agents (large or small molecules) required
- Professional Experience: 5 -8 years experience (including Post Doc)
- Knowledge and experience in Good Clinical Practices
- Good communication skill on both internally and externally, and open mind to share with others
- Well developed, advanced knowledge and skills in an applied research area of their specialization
- Demonstrated capability to supervise and mentor less experienced personnel
3
Experience For Clinical Scientist Lead Resume
- Uses resources appropriately and effectively to complete tasks and meet required timelines
- Clinical development experience required, early development experience highly desired
- Preferably with prior experience in the scientific aspects of design and conduct of large and/or complex phase 2/3 clinical trials
- Personnel managerial skills
- Prior clinical research experience in these therapeutic areas: GI, endocrinology, metabolic diseases, rare diseases or CNS
- Professional Experience: 3 - 5 years of relevant industry experience
4
Experience For Senior Clinical Scientist Medical Imaging Informatics Resume
- Eager and able to effectively teach/articulate complex scientific or technological concepts to colleagues and customers
- Understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audience
- Excellent in reading; evaluating and appraising scientific literature related to a device
- Experience analyzing complex data and presenting it to varying levels of audience
- Experience in providing support to advisory boards, consultant meetings and investigator meetings (including preparation and delivery of presentations)
- Experienced in pulse programming and programming languages
5
Experience For Executive Director, Clinical Scientist Resume
- Experience managing clinical trials in cosmetic, personal care, pharmaceutical or OTC industries
- Experience conducting investigator site and vendor qualifications
- >3 years of experience in writing Clinical Evaluation Reports preferably from the Medical Device Industry
- Demonstrated proficiency in using systems and technologies to achieve work objectives
- Rich experience working with physician
- Have experience on designing Healthcare IT products
- Good understanding of cell culture techniques
6
Experience For Microbiology Clinical Scientist Resume
- Good business acumen /commercial understanding
- Participate in large project/validation teams for new products and processes
- Solid understanding of medical imaging
- Has considerable Investigational New Drug (IND) filing experience
- Broad experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance
- Publications experience and familiarity with the peer review process
- Demonstrated clinical knowledge with expertise in at least one patient care pathway
- Relevant therapeutic area experience required
7
Experience For Senior / Clinical Scientist Resume
- Practical experience in clinical trial strategies, methods and processes
- Capability of innovative, Strong accountability and initiative; Passion for new business
- Good at English and Strategic Presentation
- Demonstrated ability to work in matrix with wide spectrum of cross functional team members collaboratively
- Experience supporting clinical research, drug development and/or therapeutic area operations
- Assists Data Management in the creation, updating and validation of clinical study databases based on project specific guidelines
8
Experience For Clinical Scientist, Clinical Development Resume
- Proven record of successful projects
- Hands-on experience in independent design, implementation and interpretation of clinical or scientific studies
- Relevant experience of clinical research and development in the pharmaceutical industry and/or in a Contract Research Organization (CRO)
- Strong collaboration with cross functional team members
- Demonstrated track record in cognitive neuroscience with application to human measurement and study in a variety of patient populations
- Knowledge and experience to conduct activities in compliance with regional/global regulatory requirements
- Experience with design and execution of clinical studies
- Experience in external, customer-facing relationships, with key opinion leaders (KOLs) and institutions/organisations involved in HIV research
9
Experience For Senior Associate, Clinical Scientist Resume
- Experience in HIV clinical research in the pharmaceutical industry
- Clinical trial experience with study design
- Infectious disease therapeutic area experience
- Experience in the infectious disease therapy area
- ≥ 5 years experience in clinical research/development or related area
- Understands the necessity of a strong partnership with colleagues eg. Clinical Operations, Regulatory, Safety
- Interpret complex data outputs and prepare solid interpretations/discussions,
10
Experience For MR Clinical Scientist Resume
- Previous work experience with hospital information systems
- Deep technical knowledge and experience with Clinical informatics e.g. (CDS, FHIR, HIS/RIS/LIS/CDSS/PACS/EMR, HL7 V3/HL7 RIM/Continua/DICOM/CDA/IHE)
- Demonstrated ability to work in cross-functional teams and with individuals
- Evidence of ability to rapidly learn clinical development role and performance of its associated tasks is required
- Experience an international and diverse work environment
- An international and modern workplace with good employment terms and offerings within health and lifestyle
- Good opportunities for development, not only of the role itself, but also for personal development
List of Typical Skills For a Clinical Scientist Resume
1
Skills For Senior Clinical Scientist Resume
- Work effectively both independently or in a team setting, and to meet set goals by managing own timelines
- Experience in data processing, statistical analysis and the development of study analytical plans for biomedical research. Clinical trials experience is ideal
- Experience in study planning, conduct and management of oncology studies - specifically first-in-human / Phase Ib experience
- Generating report of priors and/or investigational brochure
- Good understanding of scientific bases understanding of Immunology and (MS) Multiple Sclerosis
- Experience in designing and conducting Phase II-III clinical trials; and/or
- Analytical Thinking/Problem Solving/ Good Judgment
- Experience designing and conducting biomedical research ideally pharmaceutical clinical trials
- Strong market foresight, teaming and learning agility
2
Skills For Principle Clinical Scientist Resume
- Experience in scientific/medical/regulatory writing preferable
- Experience in the Medical devices industry, preferably Radiology/ Oncology or Imaging Systems
- PhD of Science in Medical Science/bio-medical engineering or substantial industry experience in the Radiology/ Oncology field
- Experience including motion biosensors in research studies, ideally pharmaceutical trials
- Strong and in-depth understanding of team work and high-performance teams
3
Skills For Clinical Scientist Lead Resume
- Conscientious, influential person with an outstanding work ethic and strong personal discipline
- >6 years work experience on Product/Marketing or Product/Sales in Healthcare industry
- Strategic thinking; Open minded and Excellent Communication capability to efficiently influence others
- Overseeing and participating in Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs) for EU MDR compliance
- Assisting during in-house testing of prototype hardware and software
- Reviewing and approving protocol training material
- Working on oncology clinical data-reviewing data, ensuring accuracy of data of the oncology clinical data
- Establishing a global network of contacts in the scientific Diagnostic Imaging community
4
Skills For Senior Clinical Scientist Medical Imaging Informatics Resume
- Developing and maintaining clinical roadmaps
- Working in multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics
- Reviewing and providing input on statistical analysis plan
- Reviewing and providing input on case report forms
- Reviewing and approving study-specific processes
- Developing study level publication plan and driving publications
- Reviewing and assessing proposals for physician-initiated studies for assigned therapeutic area
- Ensuring CERs are updated to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR
5
Skills For Executive Director, Clinical Scientist Resume
- Advising colleagues in R&D department on new technical and clinical developments
- Interacting with Clinical Scientists on sites, provide first-line helpdesk support for research related questions
- Working closely with cross-functional teams to interpret device performance information in clinical settings and in patient use
- Willing to travel (about 4-6 trips per year)
- Generating protocol synopsis and protocol
- Maintaining literature and competitive information on trial designs and results for assigned therapeutic area
6
Skills For Microbiology Clinical Scientist Resume
- Generating pre-approval clinical study reports
- Bring in the heath economic perspective as a part of disease management
- Understanding of US/EU Regulatory requirements, GCP, ICH guidance
- 6 Participate in analyzing and interpreting data from clinical studies, and writing/editing or reviewing results
- Provide scientific input to clinical research activities, including protocol development, study implementation, analysis and reporting of results
- Advise colleagues in Product Marketing and Applications on new technical and clinical developments, assist in writing commercial and technical documents
7
Skills For Senior / Clinical Scientist Resume
- Interest in and passion for research, bringing medical innovations to market and working in multidisciplinary teams
- Serve as a resource to address medical questions or clarify issues arising during conduct of the study
- Coordinate advisory meeting agendas, activities and slide decks and consulting agreements.
- Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, for Pfizer site facing roles and vendor / CRO staff
- Provides scientific input to and review of CSRs including writing of narratives
- Provide specific medical/protocol training for site facing roles
8
Skills For Clinical Scientist, Clinical Development Resume
- Provide site medical/protocol training for use during site initiation visits
- Provide protocol training at the investigator meeting
- Lead or participate in study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB management
- Provides medical perspective in consultation with the CPM during the development of the monitoring plan
- Along with the CPM and other study team members, participates in training of Study Management Staff and monitoring staff
- Participates in developing training strategy for study with the study team members
- Contribute to the authoring and revision of regulatory submissions
- Develop state-of-the-art MRI pulse sequence and post-processing softwares
9
Skills For Senior Associate, Clinical Scientist Resume
- Participates in recommending scope, complexity and size, and influence the budget of all aspects of a program
- Produce work of the highest quality by paying attention to detail
- In-depth knowledge of the laboratory organization, policies and procedures including technical safety procedures and information system functions
- Relationship Building/Flexibility/Teamwork and Collaboration
- Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)
- Basic understanding of the fundamentals of clinical research
- Self-starting and innovative thinker
- Expert in navigating scientific literature, interpretation of data, display of data
- Flexibility and adaptability, able to thrive in dynamic working environment
10
Skills For MR Clinical Scientist Resume
- Responsible for providing scientific support for the company’s clinical research and product development initiatives under the direction of GCDL/GDTL
- Act on behalf of Medical Monitor (GCDL) leading the interpretation of trial data and development and review of clinical study documents, reports etc,
- Medical monitoring of clinical data
- Data Management and Statistics, Safety and Pharmacovigilance, Clinical Operations, and Medical Writing groups Vendor, CRO and external partnerships
- Assist in writing commercial and technical documents
- Participate in customer presentations and scanner demonstrations during commercial visits
- Liaise with equipment service engineers to co-ordinate routine servicing/upgrades and attendance in the event of breakdowns
List of Typical Responsibilities For a Clinical Scientist Resume
1
Responsibilities For Senior Clinical Scientist Resume
- Able to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills
- Good understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills
- Effective oral and written communication skills and the ability to influence, negotiate, and communicate with project team
- Extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
- Can effectively work across multiple projects within a designated therapeutic area
- Managing collaborators/KOLs expectations whilst maintaining excellent relationships
- Assist in conducting efforts to obtain external scientific and clinical validation of clinical research protocols
- Experience in one or more of the following TAs: CardioMetabolic, CNS, Immunology, Oncology, Respiratory
2
Responsibilities For Principle Clinical Scientist Resume
- Proven ability to work independently and in a team setting is essential
- Experience in medical or technical writing
- Experience supporting clinical research, drug development and/or function/therapeutic area operations
- Experience of clinical trial management or oversight (GCP, ethics, feasibility, documentation and data handling & dissemination, HCP/HCO interactions)
- A PharmD, PhD, or PA with at least 5 years of experience in planning, executing, reporting and/or publishing clinical studies
3
Responsibilities For Clinical Scientist Lead Resume
- Postdoc experience working with a radiology department at a US academic medical center
- Experience working in a medical device company incl. with systems, diagnostics, applications, and software
- Documented scientific merits and teaching experience are advantages
- Knowledge and experience with Medical Devices Directive 93 / 42 /EEC
- Knowledge and experience with MEDDEV 2.7.1 Clinical Evaluations
- Knowledge and experience with MEDDEV 2.12-2 PMCF
- Knowledge and experience with GHTF SG5/N2R8: Clinical Evaluation
- Knowledge and experience with EN ISO 14155 Clinical Investigations
4
Responsibilities For Senior Clinical Scientist Medical Imaging Informatics Resume
- Knowledge and experience with ISO14971 Risk Management
- Pharmaceutical and / or clinical drug development experience
- Min 5 years of relevant experience from Healthcare or Pharma
- Previous experience within Sleep and/ or Respiratory care
- Providing medical input to business strategic plans including Launch plan and budget planning
- Participating in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
5
Responsibilities For Executive Director, Clinical Scientist Resume
- Leveraging guidelines for optimal product positioning and market expansion
- Ensuring that the needs of relevant organized patient groups are incorporated into the strategy planning and execution
- Performing research as needed to provide applicable information about new technology in Diagnostic Imaging
- Understanding of relevant therapeutic area
- Understanding of major regulations (US FDA, EMA AND PDMA)
- Understanding of relevant therapeutic area - CNS
6
Responsibilities For Microbiology Clinical Scientist Resume
- Understanding of clinical trial design and execution
- Participating in the laboratory’s quality assurance plan, adhering to all regulatory policies,
- Training in analysis of clinical and basic research information
- Adept at partnering with a diverse team and delivering results through taking ownership of crucial program components
- Adept at working in a global setting and matrix environment
- Ensures that the product application/solution is functioning according to
- Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
- Assist with ongoing monitoring of safety data and regular medical review of clinical trial data
- Success managing projects, understanding of the scientific and/or technical components of the clinical development process and regulatory requirements
7
Responsibilities For Senior / Clinical Scientist Resume
- Work with safety, data management teams and Data Monitoring Committee to make timely decisions regarding study objectives
- Assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication
- Exp. assisting/preparing in preparation of clinical study protocols
- Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
- Ensure compliance with the Ionising Radiation Regulations
- Create protocol training materials for site management
- Lead clinical input for and participate in study set up and design including data collection tools, data analysis, and database set-up
8
Responsibilities For Clinical Scientist, Clinical Development Resume
- Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables throughout the process
- Responsible for review of patient level data across a study and for coordinating with Lead Clinician for study level review as delegated
- Support initial review of clinical data in the clinical database by conducting clinical data review, analysis and interpretation
- Participate in due diligence activities in evaluating new opportunities
- Positively influence internal and external stakeholders, including internal global and matrix teams
- Preferable track record of leading Scientific engagement and meetings
9
Responsibilities For Senior Associate, Clinical Scientist Resume
- Remains up to date on current information regarding regulations and guidelines for their therapeutic area
- Collaborates with the Lead Clinician to provide medical/scientific guidance during the execution of the study
- Provides input during vendor selection for specific medical/protocol issues
- Report SAEs during Safety Review Team meetings
- Provide in-depth scientific/medical input, review and editing of clinical study reports (CSR)
- Provide input during budget creation to Clinical Program Lead and Lead Clinician
- Provide input into the preparation of study level training materials in collaboration with CPM and team members
- Sound knowledge to conduct literature searches and researching clinical information
10
Responsibilities For MR Clinical Scientist Resume
- Significant knowledge of basic and translational research and an understanding of applications to cancer drug development are required
- Play a key role in the medical review of study data and assist in coding, analysis and documentation of Company clinical work
- Proficient in Microsoft Office software, including Word, PowerPoint and Excel; high computer literacy and ability to learn new software if required
- Work dynamically including from a home office, from a hospital or clinical site, and
- Interface directly with the medical, writing, and operational functions to support the development of anti-cancer therapeutics
- Advanced understanding of appropriate technology necessary to analyze clinical study data, generate reports and create presentations, posters and manuscripts
- Learn and follow all SOP’s under GCP guidelines
- Combining knowledge of chemistry/radiochemistry/physics/biology or software/system engineering or computer science (depends on area of specialty) to develop and deliver new MR applications
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