Clinical Trials Manager Resume Sample

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Chaz Pollich
215 Chadrick Stream,  Los Angeles,  CA
+1 (555) 951 3867

Work Experience


Clinical Trials Manager
08/2017 - PRESENT
Philadelphia, PA
  • Assists in determining the activities to support a project’s priorities within functional area
  • Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
  • Seven or more years of relevant clinical trials experience, with at least four years of experience as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
  • Develop and coordinate trials and operational activities on time and under budget
  • Review and contribute to protocols, amendments, CRFs and CSRs as well as develop informed consent documents
  • Coordinate the qualification and selection of investigative sites, plan for and present at Investigator Meeting and develop other site training material
  • Develop clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution including project, communication, monitoring, recruitment, risk mitigation and contingency plans
  • Partner with CSP in identifying appropriate vendors for possible selection
  • Manage vendor and CRO activities and track internal and external project deliverables
Senior Clinical Trials Manager
06/2014 - 04/2017
Chicago, IL
  • Responsible for ensuring the development and updating of cost estimates and the study and project level
  • Partner with the CSP team in developing complete clinical trial external cost estimates
  • Ensure CRAs assigned to a project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits. Follows up significant project issues at investigative sites
  • Ensure study execution compliance with GCP/ICH and any other regulatory project issues at investigative sites
  • Develop trial monitoring plan and track /report compliance
  • Partner with the Clinical Trial Associate I/II to ensure the TMF is developed
  • Stay current with regulation and industry trends
  • Actively communicate project issues and identifies risks. Work with drug development partners to resolve project challenges
Clinical Trials Manager, South Africa
07/2010 - 02/2014
Chicago, IL
  • Manages European component of global Phases II-III, IIIb outsourced studies managed by a Clinical Program Manager
  • Completes/Coordinates review of data listings and preparation of interim/final clinical study reports
  • Conducts oversight monitoring visits as required
  • Coordinates and supervises all aspects of a clinical study
  • Contributes to Clinical Operations Europe team activities & initiatives
  • Manages European component of global PII-III outsourced studies managed by a US-based Clinical Program Manager
  • Conducts Monitoring/co-monitoring as required
  • Contributes to Clinical Operations International team activities & initiatives

Education


Doane University - Crete Campus
2004 - 2009
Bachelor's Degree in Natural Science

Professional Skills


  • Excellent communication skills, verbal, written skills
  • Proven Management of people in a matrix environment, excellent communication skills
  • PC Skills (MS Office Suite) Communication skills (verbal and written)
  • Prior nursing experience with clinical trials in an outpatient setting and data management and collection experience
  • Excellent written and oral communication skills mandatory including command of PowerPoint, Word, Excel
  • Track record of problem solving and organizational skills with strong attention to detail
  • Excellent teamwork, communication, decision-making and organizational skills are key to success

How to write Clinical Trials Manager Resume

Clinical Trials Manager role is responsible for microsoft, excel, interpersonal, training, database, recruiting, auditing, refining, security, oncology.
To write great resume for clinical trials manager job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Clinical Trials Manager Resume

The section contact information is important in your clinical trials manager 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
  • Email
  • Telephone number

Work Experience in Your Clinical Trials Manager Resume

The section work experience is an essential part of your clinical trials manager 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 trials manager 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 trials manager position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Clinical Trials Manager resume experience can include:

  • Delegate tasks to direct reports, with the ability to coordinate and allocate responsibilities based on complexity of work and skill set of CTMs, CTMAs and CPAs
  • Possess good critical thinking skills with a focus on inspection readiness
  • Emerging vendor management skills
  • Use problem-solving skills to identify and resolve unique and unexpected issues in a logical, timely, creative manner
  • Proficiency using Microsoft Office applications; Advanced skills with SharePoint and MS Project
  • Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel

Education on a Clinical Trials Manager Resume

Make sure to make education a priority on your clinical trials manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical trials manager 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 Trials Manager Resume

When listing skills on your clinical trials manager 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 trials manager skills:

  • Solid Project Management and analytical problem solving skills
  • Possesses excellent written and oral communications skills
  • Excellent written and interpersonal skills to be able to interact with internal Vertex personnel as well as external groups (CROs, sites, others)
  • Experience in pharmaceutical industry or clinical-related discipline including at least 8 years clinical research experience
  • Prior management and/or supervisory experience in coordinating international clinical trials is required
  • Demonstrates detailed understanding of clinical protocol , intended study populations as well as solid overall drug development

List of Typical Experience For a Clinical Trials Manager Resume

1

Experience For Senior Clinical Trials Manager Resume

  • Strong computer science and engineering knowledge with system building experience
  • Proficient Microsoft Office skills and knowledge of Interactive Response Technology and databases
  • Provide oversight of TMF documentation and QC in accordance with Good Documentation Practice, Good Clinical Practice
  • Displays sound project management skills to independently manage TMF projects with some supervision
  • Demonstrated computer literacy; proven functional knowledge of Microsoft packages and ability to develop
  • Familiar with ERP system user acceptance testing and validation requirements
  • Experience actively managing studies in rare disease, hematology or oncology trials
  • Clinical trials management experience
  • Experience as a Clinical Trial Manager, Clinical Study Manager or Clinical Project Manager
2

Experience For Associate Clinical Trials Manager Resume

  • Five or more years of relevant clinical trials experience
  • Prioritize work accordingly to meet departmental needs and work toward and meet deadlines with some supervision
  • Demonstrates ability to communicate and coordinate activities within the group and all TMF Stakeholders
  • Maintain good working relationships with investigators, study staff, Astra Zeneca/Merck, CTEP, comprehensive research solutions, Phastar, Theradex
  • Previous exposure to/experience handling human biological specimens
  • Working knowledge of Clinical Trial Materials development, manufacturing, packaging and labeling
  • Defining or translating the scope of all project related deliverables and corresponding timelines as it relates to staff workflow,
3

Experience For Clinical Trials Manager, South Africa Resume

  • Planning and tracking of all assigned clinical activity in the lifecycle phases of the start up,interim and close out
  • Working knowledge of establish and managing partnership with CMO and CRO
  • Tracking project completion status and ensuring continuity of workflow to ensure project completion and timelines,
  • Generating and maintaining project related metrics to determine outcomes,
  • Working knowledge of supply and distribution operation
  • Coordinating activities related to completion of projects, deliverables and project timelines,
  • Negotiating project related timelines as applicable,
4

Experience For Lead Clinical Trials Manager Resume

  • Functioning as a liaison between external customers (e.g., sponsor entity), investigators and staff with respect to project related deliverables and timelines,
  • Collaborating with departmental managers to identify workflow issues and resolutions,
  • Performing quality control and assurance for specified project related work
  • Knowledge of developing and managing an interactive enterprise system for managing resource or assets
  • Facilitate efforts to identify potential subject safety issues by obtaining relevant data and distributing and/or reviewing reports
  • Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File
  • Participate in study start-up activities including protocol authoring, database design, study manuals, essential documents etc. with the mindset of “start
  • Manage all Safety Reports in TMF and Investigator portal systems, including: QC, distribution and tracking
5

Experience For Clinical Trials Manager, Oncological Sciences Resume

  • Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required
  • Provide strategic guidance of junior staff given acute insight on the monitoring of clinical sites
  • Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System
  • Drawing on knowledge and relationships with sites’ operations, provide input to protocol teams on site expertise and potential obstacles and challenges
  • Tracking of site visits, communication with monitors and sites, and other activities as assigned
  • Confirm patient eligibility and discuss discrepancies with nursing staff and physicians
  • Verify screening procedures are performed within the protocol specified window
  • Capable of handling at least 1-2 enrollments per week
6

Experience For Clinical Trials Manager Neurosurgery Days Msh Resume

  • Interfaces with laboratory technician for lab kits and processing
  • Participates in monitor visits for each assigned trial at each monitoring visit
  • Reviews source documentation and queries for missing documentation
  • Reports patient visit and data entry information in financial tracking system
  • Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and
  • Assists the Clinical Trial Manager in ensuring compliance with Clinical Study Protocol and provides timely
  • Assists Clinical Trial Manager in site management activities which could include review of monitoring report,
  • Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification, and laboratory manual
7

Experience For Data Management Clinical Trials Manager Resume

  • Manage external vendors and contract research organizations involved in the conduct of an exciting rare disease clinical trial
  • BA/BS in Nursing or Science related discipline
  • Assists with ongoing review of the TMF and checks document compliance for active and archived projects
  • Ensure that project documents are maintained per relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs)
  • Act as central point of contact for vendor providing this service
8

Experience For Clinical Trials Manager, Beijing Resume

  • Enter, track and route contracts for legal input and approval using business systems and sharepoint
  • Conduct content review of a variety of documents in a short time frame while maintaining consistency and attention to detail
  • Generates metrics for study team consumption supporting TMF completeness and accuracy
  • Leads the execution of trials for the research team
  • Collects, completes and enters data into study-specific case report forms or electronic data capture systems within 10 business days of patient visits
9

Experience For Clinical Trials Manager Resume

  • Monitor patient toxicity on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record
  • Planning and tracking of all assigned clinical activity in the lifecycle phases of the start up, interim and close out
  • Educates Research Nurses on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
  • Creates study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)
  • Ensures study specific tools, including source documents, are updated with any amendment(s) or study changes
  • Ensures pharmacist has clinical and drug supplies
  • Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations
  • Reviews and comments on monitor letters within 5 business days of receipt
  • Reviews trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance
10

Experience For Senior Clinical Trials Manager Resume

  • Reviews and responds to any monitoring and auditing findings and escalates issues defined by Project Manager
  • Archives study documentation and correspondence per company policy
  • Participates in sponsor meetings when applicable
  • Provide required metrics to leadership
  • Adhere to professional standards and SOP’s established for clinical research
  • Communicates and escalates unresolved issues at the appropriate time to the appropriate level of management
  • Keeps management abreast of issues and progress on all assigned projects and the projects of team members
  • Reports metrics on all assigned projects and the projects of team members

List of Typical Skills For a Clinical Trials Manager Resume

1

Skills For Senior Clinical Trials Manager Resume

  • Seven or more years of relevant clinical trials experience, with at least four years of experience as a travelling CRA in the pharmaceutical industry
  • Experience in clinical trial management (study management experience)
  • Experience in clinical trial management (study/trial management experience)
  • M.S. (or equivalent experience) and 4+ years of relevant work experience
  • B.S. (or equivalent experience) and 6+ years of relevant work experience
2

Skills For Associate Clinical Trials Manager Resume

  • Experience with Auto-Immune, Rare Disease, Hospital Based products and/or drug device combinations experience in
  • Experience with Auto-Immune, Rare Disease, Hospital Based products and/or drug device combinations experience in late stage trials
  • Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired
  • Experience managing clinical trials, including 2 years in management/ leadership role
  • Develops database (DB) clinical trial data specifications, including eCRF design, user requirements, edit the rules/checks, query logic and data validations
  • Experience writing clinical protocols, informed consent forms and various other clinical documents
  • Experience posting clinical trial information and data with regulatory agency
3

Skills For Clinical Trials Manager, South Africa Resume

  • Proven Management of people in a matrix environment
  • Management work experience in the healthcare or clinical trial space
  • Experience in clinical research with 5+ years’ in study management
  • Clinical study management experience with global clinical studies
  • Min. of 2 years of CRO experience required
  • Clinical trial and site management experience
  • Experience in Quality Affairs
  • Clinical vaccine trials research experience
4

Skills For Lead Clinical Trials Manager Resume

  • Experience in healthcare, research or other science related field is required
  • Proven ability to provide scientific and clinical expertise in all phases of clinical trial
  • Trial management experience
  • Monitors and reports adverse events, protocol deviations, and safety issues, assisting with specimen collection and processing
  • Reconciles electronic data transfers from vendor to Sponsor and performs training on study trials for in EDC (Electronic Data Capture, creating user guides
  • Prepares IRB submissions, amendments, adverse events, deviations, continuing reviews and maintains IRB documentation for each study
  • Completes data collection and recording for study participants
  • Develops forms, databases and writes standard operating procedures for data collection of non-sponsored research projects
  • Instructs patients, families and hospital personnel regarding research requirements
5

Skills For Clinical Trials Manager, Oncological Sciences Resume

  • General office, warehouse and laboratory setting
  • Visual and manual acuity for working with computers and equipment
  • An understanding of how to analyze clinical trial data
  • Protocol/amendment development (including review of all applicable literature such as SBAs, FDA guidance’s, and other publications)
  • Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
  • Mallinckrodt strives to be an employer of choice, offering a robust suite of benefits, flexibility and competitive compensation
  • INTEGRITY Doing What’s Right
  • Helps research coordinator and principal investigator with various tasks
  • Organizes and maintains research subjects’ original informed consent, HIPAA, and all source documentations in proper order in 10 ongoing clinical trials (Phases II-IV of the clinical trials process)
6

Skills For Clinical Trials Manager Neurosurgery Days Msh Resume

  • Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements
  • Monitors Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
  • Maintains and tracks EDC user management and other clinical databases across allocated clinical trials, including but not limited to compiling master user lists and activating/deactivating user accounts
  • Ensures clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock including data reconciliation and/or coding
  • Assists in defining and/or creating data listings, summary table validation, data specifications, and/or process data transfers in preparation for statistical review and/or data management audit
  • Facilitates effective communication between study sites and study team members to ensure ongoing successful execution
7

Skills For Data Management Clinical Trials Manager Resume

  • Lead cross functional teams and work with your partners in Medical Science, Regulatory, Data Management, etc
  • Builds, manages, and maintains budgets, contracts and timelines for a given clinical trial
  • Manages all aspects of clinical research from project proposal, Institutional (IRB) preparation and approval, study initiation, data analysis and close out
  • Monitors regulatory compliance with all study personnel
  • Recruits patients/participants for clinical research studies potentially at off-site clinics
8

Skills For Clinical Trials Manager, Beijing Resume

  • Coordinates industry-supported, clinical research opportunities
  • Reviews and assists with budget preparation
  • Contributes to application process for research grants/contracts to support departmental studies
  • Potential travel to industry sponsored research meetings
  • Exercise discretion, make independent judgments, and work independently
  • HIPAA and human subjects’ certifications
  • Use in-depth knowledge of business unit functions and cross group dependencies/relationships
9

Skills For Clinical Trials Manager Resume

  • Interpret, synthesize and communicate complex medical and scientific information required
  • Conduct and hear ordinary conversation and telephone communication
  • Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
  • M.S. (or equivalent experience) and 2 – 4 years of relevant work experience
  • B.S. (or equivalent experience) and 3 – 6 years of relevant work experience
  • Up to 75% International and domestic travel
  • Fluency in Latin American Spanish and Brazilian Portuguese
  • Manage multiple timelines and perform under strict deadlines
  • Knowledge of FDA guidelines and GCP is required
10

Skills For Senior Clinical Trials Manager Resume

  • Research Professional Certification, CCRP, or exam eligible
  • Knowledge of cGCP, ICH, and FDA regulatory requirements
  • Complimentary Coffee/Fruit Smoothie Bar, Health Club, subsidized cafeteria and a fun, “jeans allowed” work environment
  • Travel required up to 20-25% of the time
  • Coordinate team efforts internally and externally in maintenance and upgrading Client’s Clinical Inventory Management System (CIMS) that is based on Smart Supplies PMD and RAR platforms. Responsible for leading, executing and refining organizational strategies and standards in ClMS

List of Typical Responsibilities For a Clinical Trials Manager Resume

1

Responsibilities For Senior Clinical Trials Manager Resume

  • Responsible for training, education and mentoring Clinical Trial Manager I, Clinical Trial Manager II and Data Coordinators; mentors and coaches new and /or junior data management staff
  • Strong skills in facilitating and building consensus in an interdisciplinary team environment
  • Self-motivated and able to work independently with minimal supervision using strong organizational, project and time management skills
  • Experience conducing the following: PSVs, SIVs, IMV, and COV
  • At least one year of experience planning and managing clinical trial process
  • Prioritize competing demands to successfully meet deadlines and project milestones
2

Responsibilities For Associate Clinical Trials Manager Resume

  • Previous experience in a clinical setting, specifically clinical trials
  • Knowledge of multiple sclerosis and experience working with patients
  • Understanding of Sponsor role and responsibilities required
  • Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
  • Assists in training new staff
  • Current CITI Group 1 Biomedical, HIPAA, and IATA Training
  • Work directly with the Biometrics group to obtain pertinent study data for posting
  • Participates in monitor visits monthly, on average, for each trial assigned and reviews source documentation and queries for missing documentation
3

Responsibilities For Clinical Trials Manager, South Africa Resume

  • Maintains case report forms tracking management database and reviews trial data for clinical relevance and answers appropriate queries
  • Build successful working relationships with relevant network partners
  • ACCOUNTABILITY Taking Personal Responsibility
  • CITI Human Subjects Protection, HIPAA, and GCP training
  • INCLUSION Encouraging Diversity
  • EXCELLENCE Being Your Best
  • TEAMWORK Working Together
  • Review and approval of source document forms for implementation
4

Responsibilities For Lead Clinical Trials Manager Resume

  • Provide back-up support and data entry assistance as needed for team members
  • Educates Research Nurses on protocol modifications and specifications including visit schedule,assessment windows, dose modifications, central and local laboratory assessments
  • Reviews and comments on follow up monitor letters within 5 business days of receipt
  • Reviews trial data for clinical relevance and answers appropriate queries
  • Apprises research scientists and management team of all study specific medical issues for guidance
  • Ensured research activities comply with local regulatory requirements, Haemonetics’s SOPs, GCPs, and that audit readiness is maintained throughout trial conduct
  • Reviews sponsor protocol edits and Informed Consent Form (ICF) edits, case report forms, study templates and manual of operations
5

Responsibilities For Clinical Trials Manager, Oncological Sciences Resume

  • Perrigo Company is an EOE
  • Assists Clinical Trial Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
  • Updates to assigned Clinical Project Manager to confirm compliance
  • Assists with preparation of all external and internal documentation, for assigned trials, to ensure such
  • Documentation is completed in accordance with GCP regulatory requirements and is consistent with the study
  • Protocol, under close supervision
  • Support CTMM specialist for CIMS in operating the system and providing protocol level support from start up, study maintenance to study close out; and providing documented training for all users worldwide
  • Lead the execution of system upgrade and interface with CTMS and other external system
  • Provide higher level of troubleshooting in CIMS, identify gaps and implement improvements to ensure data accuracy and user support to meet evolving business needs, manage the system access, integrity, interfaces and the upgrade of the system
6

Responsibilities For Clinical Trials Manager Neurosurgery Days Msh Resume

  • Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast. Conduct capacity planning to create a supply plan for all phases including complex phase III studies or dose flex adaptive studies
  • Manage operating budgets for sourced services and activities. Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure and cross-functional collaboration. Comply with ICH, Federal U.S. and any pertinent local regulations and adhere to Sepracor SOP and Guidance Documents
  • Clinical research experience or course-work equivalent in clinical research
  • Knowledge of global clinical development end-to-end process
  • Assure regulatory compliance of investigation sites with SOPs and FDA and ICH guidelines
  • With the end in mind” to ensure the operational team is poised for successful data to enable the program strategy
7

Responsibilities For Data Management Clinical Trials Manager Resume

  • Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source document
  • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations Demonstrated ability to work independently and in a team environment Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
  • Create, maintain, index and scan documents/files for all site related paper or electronic documents required in the TMF
  • User of systems and business technologies to document and track study and user progress
  • Serve as a content manager for study-specific sharepoint sites
8

Responsibilities For Clinical Trials Manager, Beijing Resume

  • Procure, print and distribute patient safety cards in multiple languages for use across studies
  • Serve as CIOMS coordinator to track and update log of investigator letters against Investigator Brochure
  • Coordinate delivery of documents to support registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study
  • Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage
  • Ensure TMF completeness and accuracy based on Vertex SOPs and regulatory requirements
  • Participate in inspection readiness reviews and preparations
  • Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
9

Responsibilities For Clinical Trials Manager Resume

  • Proficiency in relevant TMF systems and programs
  • Serve as a liaison for a multi-institutional clinical trial, between clinical and laboratory personnel and the NCI Pediatric Oncology Branch Principal Investigators
  • Assist Investigator(s) with developing IITs and preparing manuscripts for publications
  • Contribute to the writing of manuscripts, abstracts or other clinical research related documents
  • Assists Clinical Trials Manager in site management activities which could include review of monitoring report,
  • Manages and monitors clinical trials which the principal investigator is responsible for including recruitment and management of subject enrollment
  • Lead, organize, assign and track tasks assigned to the SPRINT protocol in preparation for FDA submission
  • Participate in the development of timelines, data base lock, and FDA submission
  • Assist in authoring/reviewing study plans (i.e., FDA briefing document, Data Management Plan, Imaging charter, EU drug designation request, Trial Master File, PIP, Individual patient review, etc.)
10

Responsibilities For Senior Clinical Trials Manager Resume

  • Write, review and contribute to NF1 studies, SPRINT and natural history protocol and informed consent amendments, and other study-related documents
  • Investigate queries, monitor discrepancies, maintain data integrity for the multi-institutional trial
  • Manage various aspects of day-to-day operations of clinical trials
  • Lead and participate in meetings and conference calls with multi-functional teams, Astra Zeneca, CTEP, CRS
  • Organize and manage internal team meetings and other trial-specific meetings
  • Assist the PI and study team with additional tasks as assigned
  • Assists the Clinical Trials Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
  • Manages and coordinates clinical trial and related research studies conducted by the principal investigator(s) to ensure conformance with specified research objectives and protocols

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