As a Clinical Trials Manager, the person will be responsible for managing, coordinating, and overseeing the various aspects of the clinical trial. Working often for pharmaceutical companies, private research companies, universities, and hospitals, these managers under the following tasks mentioned on the Clinical Trails Manager Resume – managing clinical trials and ensuring they are correctly executed; helping in screening potential study subjects, monitoring the progress of the study subjects, updating and contacting supervisors, and collecting data from study subjects.
Hiring employers pick those resumes denoting the following attributes – basic knowledge and a firm understanding of elementary science principles in biochemistry, pharmacology, and chemistry; in-depth knowledge of the research process, the ability to handle large and complex trials, and analytical skills. Apart from having a strong interest in medicine, pharmaceuticals, and science and at least a bachelor’s degree.
Objective : Clinical Trials Manager with 3 years of experience in Developing and implementing office policies and procedures that are consistent with those administered by the University, Hospitals, and Clinics, and federal and state contract regulations, Supervising the processing of IRBs, IDEs, and INDs.
Interacted/collaborated on behalf of the UREI with investigators, sponsors, RSRB, IRBs, and research officials.
Recruited and supervised a team of clinical trials study coordinators and assigned support staff.
Provided oversight of regulatory processes and submissions.
Collaborated with investigators and sponsors to develop study budgets and timelines.
Ensured compliance to data entry and reporting requirements, Good Clinical Practice, and safety principles.
Ensured that all studies remain in good standing and maintain appropriate accrual levels.
Developed and oversaw regular auditing/quality assurance processes for active studies.
Experience
2-5 Years
Level
Junior
Education
GED
Clinical Trials Manager Resume
Objective : Coordinating clinical trials or research for the Department of Neurology. Evaluate patients and/or potential candidates for research studies based on research criteria; collect data from family/medical histories of the patient.
Skills : CR&D Project Management, Regional CRA/Monitoring Phase I-IV In US And Canada, Clinical Research Nurse, Critical Care And OR Nursing, Clinical Trial Educator/Clinical Trial Liaison, Rare Disease/Orphan Disease.
Description :
Ensured proper development of clinical trial coordinators' resources in conjunction with study priorities.
Served as a resource for clinical knowledge.
Ensured timely subject recruitment and smooth implementation of studies by leading, guiding, and motivating site personnel to complete study goals.
Partnered with IT to develop an efficient and thorough method for User Acceptance Testing of the legacy CALGB tools.
Worked with IT to improve the quarterly CDUS reporting process.
Represented Flatiron directly with life science partners primarily in Clinical Operations and Study Management.
Developed and fostered strong working relationships with these stakeholders.
Experience
2-5 Years
Level
Junior
Education
Masters Of Science
Clinical Trials Manager Resume
Headline : Clinical Trials Manager with 3 years of experience in Performing a physical assessment of the patient as appropriate and record all data pertinent to the research and nursing/medical care of the patient, Serving as informational resource contact between principal investigators, pharmaceutical companies, University Hospital and Office of Research.
Skills : Clinical Research, Multitaking.
Description :
Achieved clinic goals, including both monthly and trial specific performance.
Managed all components of multiple clinical trials from protocol inception through completion.
Oversaw the development of study documentation including, but not limited to clinical protocols, informed consent templates, case report forms, source worksheets, pharmacy manuals, delegation of authority logs and other site tools.
Maintained project timelines during the planning, initiation, ongoing/active and study completion stages of clinical trials.
Gathered input from cross-functional teams and create plans that help the team produce deliverables according to timeline.
Assisted investigators by identifying issues, offering solutions, and following to resolution.
Read and critically interpret relevant literature.
Experience
5-7 Years
Level
Executive
Education
G.E.D
Clinical Trials Manager Resume
Objective : Experienced leader in the area of clinical trials data management covering Phase I-IV trials in Oncology and Neurosciences. Experience managing trials in both the pharmaceutical and academic research settings. Twenty plus years staff management from hiring, talent review and budget allocation. Expertise in vendor management and assessment from off-site suppliers to service providers. Strategic oversight in technology implementation, process planning, development and evaluation including Inform, Medidata Rave and ePRO.
Skills : LPN, Multitasking, Planning Skills.
Description :
Managed the Data Coordination group to ensure CALGB / Alliance project timelines were met and appropriate resources were assigned.
Worked with Statistics to identify effective project solutions to meet disease committee and study deliverables.
Worked with colleagues at Mayo clinic and NCI to ensure an integrated rollout of Medidata Rave including process and data standardization.
Managed study workload assignments and issues across all therapeutic areas for Alliance studies, partnered with statisticians and other members of the study team to ensure the goals of the study were met.
Provided management and leadership support for DM staff members.
Conducted interviews and managed the hiring process for open DM positions.
Planned and led monthly DM meetings.
Experience
2-5 Years
Level
Junior
Education
GED
Clinical Trials Manager Resume
Objective : Responsible Clinical Trials Manager with excellent communication skills demonstrated by 8 years of experience in the clinical research healthcare environment. Proven leadership and mentoring skills. Meticulous and detail-oriented with data entry, monitoring, and quality assurance of clinical trials. Directing and implementing new Standard Operating Procedures and managing clinical trials.
Skills : Microsoft, Data Entry, Database Management, Quality Assurance, Quality Control, Quality Management, Medical Terminology, Specimen Collection, Management Skills, Monitoring.
Description :
Created Standard Operations Procedures to recommend improvements in quality assurance and control across all clinical research entities.
Led clinical project meetings with department staff to review project status and proposed changes.
Trained fellows and new employees in Good Clinical Practices.
Created templates for research documentation such as eligibility checklist, consent notes, progress notes to be entered in the electronic medical records system.
Monitored team progress and enforced data entry deadlines.
Updated and managed 10 clinical trials in a database.
Reviewed and audited all data entry under the Clinical Trials Database (CTDB).
Experience
2-5 Years
Level
Junior
Education
Masters Of Science
Clinical Trials Manager Resume
Headline : Preparing the annual budget and monitor revenue expenditures during the year, Researching possible funding sources for grants to generate an increased number of drug trials and medical device trials from the industry.
Skills : Clinical Skills, Multitasking, Communication Skills.
Description :
Managed personnel functions such as hiring, merit recommendations, promotions, transfers, and vacation schedules.
Managed and coordinated assigned multi-site and large-scale clinical trials research studies conducted by a supervising principal investigator.
Coordinated and established clinical trial schedules, task assignments, and allocation of manpower and equipment to ensure compliance with specified objectives.
Conducted meetings with subordinates to ensure compliance with established practices, to implement new policies, and to keep employees abreast of current changes and standards.
Assisted with the development of operating policies and procedures for clinical trial operations.
Established guidelines for the collection of clinical data and the administration of clinical trials.
Provided guidance as needed to clinical trials coordinators and Clinicians.
Experience
5-7 Years
Level
Executive
Education
BS
Clinical Trials Manager Resume
Objective : Planning, conducting, and overseeing detailed assessments of Flatiron's site network; communicating and working directly with site trial and clinical staff; develop and oversee Flatiron's site network profile, and communicate both detailed and summary-level information to internal leadership and clients.
Skills : Clinical Skills, Management Skills, Time Management.
Description :
Changed positions while at this facility to manage clinical trials.
Managed over 30 oncology studies concurrently.
Participated in oncology clinical trials.
Ran and coordinated internal audits on non-IND protocols.
Ensured physicians, patients, and all other healthcare workers adhered to following the protocol of their specific oncology study.
Assisted with recruitment, consents, and retention of subjects, completed CITI training, IRB assistance, monitored and reported AEs and concomitant medications, processed specimens, and attended weekly physician team meetings.
Worked with the CROs and monitors of the industry trials.
Experience
0-2 Years
Level
Entry Level
Education
ADN In Nursing
Clinical Trials Manager Resume
Summary : A respectful, efficient Clinical Trials Manager professional with 12+ years' project management/coordination skills and healthcare/medical exp looking to work for your company in any managerial capacity.
Provided oversight of all activities involved with securing, monitoring, and evaluating the results of clinical trials, Prepared and executed the clinical study Coordinated Pre-IRB protocol review process, Developed research documents in compliance with protocol monitoring guidelines.
Managed and maintained required clinical and regulatory files Conducted clinical monitoring in accordance with FDA regulations, Medstar SOPs, and study-specific sponsor SOPs Conducted training sessions on protocol procedures, requirements, and documents.
Served as operational contact between the sponsor, principal investigator(s), and Medstar Instrumental with protocol implementation and document processing for clinical trials Developed new study applications and related documents Monitored patient's study progress to fulfill protocol and sponsor requirements.
Coordinated, documented, and discussed patient evaluation, problem list, and plan of care on a daily and supplemental basis with the attending physician Conducted timely reassessments of patient responsiveness to therapy with appropriate documentation and communication of changes.
Managed the fiscal performance of the study through the negotiation of investigator budgets Effective management of departmental budget through review of return on investment for study costs and payments to investigators and contracted services Prepared and analyzed monthly research activity reports and provided recommendations to the appropriate authorities based on outcome results.
Responsible for the International Business Unit.
Led or collaborated on required tasks prior to commencement of clinical trials that include, but are not limited to clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials, and training.
Experience
10+ Years
Level
Senior
Education
MS
Clinical Trials Manager Resume
Summary : Self-motivated individual with over 15 years' experience in research with a strong sense of urgency on prioritizing and completing tasks to meet overall budgets and timelines Engaging and influential speaker having effectively delivered over 50 large and small group presentations for Investigator Meetings, internal training/education, and SIVs.
Provided clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.
Communicated with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and closeout study visits to ensure compliance with protocols and GCP requirements.
Collaborated on clinical data processing in accordance with departmental SOPs and guidelines.
Verified, reviewed, and tracked CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system.
Assisted in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions.
Assisted in tracking study-specific payments.
Provided operational or workflow support to assure that departmental and cross-functional systems and procedures are efficiently and correctly completed.
Experience
10+ Years
Level
Senior
Education
Ph.D. In Molecular And Cellular Biology
Clinical Trials Manager Resume
Headline : Identifying and steer process development and process improvements across the trials organization intended to define, implement, and enhance fit-to-purpose research foundations based on regulatory requirements, industry best practices, and internal commitments.
Collaborated on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality/Compliance.
Led or collaborated on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews.
Liaisoned between internal and external stakeholders to facilitate the cooperation of others.
Conducted presentations of clinical information concerning specific projects.
Worked on projects of the moderate-to-high degree of difficulty in which analysis of situation or data requires a review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated.
Assisted principal investigators with grant protocol, budget preparation, and pre-contract review.
Negotiated fees with hospital laboratory, radiology, and pharmacy for principal investigators.
Creating an account is free and takes five seconds.
You'll get access to the PDF version of this resume template.
Choose an option.
Sign up with Google
Sign up with Facebook
Sign up with Linkedin
This helps us make sure you're human and prevents spammers from abusing our services.
By continuing, you agree to our Privacy Policy and Terms.
Unlock the Power of Over 10,000 Resume Samples.
Take your job search to the next level with our extensive collection of 10,000+ resume samples. Find inspiration for your own resume and gain a competitive edge in your job search.
Get Hired Faster with Resume Assistant.
Make your resume shine with our Resume Assistant. You'll receive a real-time score as you edit, helping you to optimize your skills, experience, and achievements for the role you want.
Get Noticed with Resume Templates that Beat the ATS.
Get past the resume screeners with ease using our optimized templates. Our professional designs are tailored to beat the ATS and help you land your dream job.
