Clinical Research Manager Resume Sample
Joanne Klocko
442 Renner Highway,
Chicago,
IL
+1 (555) 914 5258
Work Experience
Clinical Research Manager
02/2017
-
PRESENT
New York, NY
- Assist in planning, writing and implementing the clinical study's goals and objectives
- Independently manage all aspects of research program and clinical studies including education/teaching
- Initiate, develop and write research related standard operating procedures
- In conjunction with Pl or Director, interpret and apply current research findings in area of clinical specialty
- In conjunction with Pl and Director, report findings in professional journals and local, state, and national conferences
- Act as a consultant within area of clinical and research expertise
- Provide direct supervision to exempt and non-exempt staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.)
- Responsible for running investigator’s meetings
- St. John’s Hospital (Oxnard, CA)
Senior Clinical Research Manager
10/2011
-
12/2016
Boston, MA
- Responsible for ongoing supervision and training of clinical research coordinators
- Responsible for assignment of staff based on identified Center needs and to ensure optimal Center operations
- Collaborate with principal investigators on all aspects of protocol development, implementation, and progress monitoring, including submissions to the Mount Sinai Program for the Protection of Human Subjects (PPHS) and the Grants and Contracts Office (GCO)
- Demonstrate expertise in Good Clinical Practice (GCP) and federal regulatory guidelines to ensure the highest quality research standards are met
- Responsible for clinical trial reporting, participation in audits, study monitoring visits, and drafting reports and responses as necessary
- Ensure all faculty and staff adhere to GCP and have appropriate training in delegated responsibilities
- Interact with research participants and families to aid in recruitment and study retention
- Facilitates timely and responsive communication and proactive responsible decision making
- Assures availability of human and material resources for safe, competent and effective deployment
Clinical Research Manager, Assoc.director
04/2009
-
08/2011
Dallas, TX
- Develops and implements ongoing quality improvement activities. Ensures safe, efficient and quality patient care by following the medical center’s policies and protocols
- Develops and maintains systems which support efficient and effective functioning of designated clinical research areas
- Provide oversight of contract workers (CRAs, CTC) and works closely with external vendors, site investigators
- Have a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries
- Make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director
- Need a strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
- Need strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance
- Be accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally
Education
National University - Fresno Campus
2003 - 2008
Bachelor's Degree in Science
Professional Skills
- Excellent writing skills and ability to effectively communicate with technical and non-technical individuals; and ability to work in a team environment
- Excellent written, verbal, and visual communication skills to represent research projects effectively to multiple audiences
- Strong organizational skills with demonstrated success
- Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential
- Demonstrate the ability to lead, motivate and communicate with others.Utilize skills to contribute to UC/UCPC strategic planning
- Excellent communication and influencing skills, high personal credibility and energy
- Strong project planning, leadership, negotiation and presentation skills, as well as an ability to contribute practical solutions to problems are required
How to write Clinical Research Manager Resume
Clinical Research Manager role is responsible for leadership, clinical, research, regulatory, computer, microsoft, english, organizational, training, analysis.
To write great resume for clinical research manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Research Manager Resume
The section contact information is important in your clinical research 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
- Telephone number
Work Experience in Your Clinical Research Manager Resume
The section work experience is an essential part of your clinical research 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 research 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 research manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Research Manager resume experience can include:
- Be the POC for assigned protocols between ROC and CO. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols
- Excellent team building skills also in cross-functional teams
- Good project management skill ( e.g. good planning, implementation and follow up) is required
- Motivate and lead an organization as well as skill in dealing effectively with people at all levels
- Strong computer skills, MS Word, Excel, Outlook, MS Project and PowerPoint
- Proven team building and people/organizational development skills
Education on a Clinical Research Manager Resume
Make sure to make education a priority on your clinical research 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 research 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 Research Manager Resume
When listing skills on your clinical research 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 research manager skills:
- Demonstrated good presentation skills
- Demonstrates knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations and other federally mandated guidelines
- Good interviewing skills – responsibility for attracting, developing and retaining personnel
- Solid decision-making and financial management skills
- Good problem solving skills - Early identification of problems and/or conflict, with appropriate analysis and mitigation plans
- Strong communication skills and outgoing, people person personality
List of Typical Experience For a Clinical Research Manager Resume
1
Experience For Senior Clinical Research Manager Resume
- Effective communication and leadership skills and ability to foster team productivity and cohesiveness
- Prior experience working with and managing clinical, behavioral, and neuroimaging data in psychiatric populations is highly desirable
- Other requirements include researching skills and expertise in searching medical literature and databases for clinical and technical information
- Stellar interpersonal skills, including the ability to communicate with Dartmouth students, faculty, administrators, support staff, and funders
- Strong experience in clinical trials research
- Ensure organizational, legal, compliance, IRB, and ethical requirements are met prior to data being shared
- Experience developing relationships with physicians and staff
- Proven track record of having successfully led one or more clinical trials
2
Experience For Oncology Clinical Research Manager Resume
- Excellent knowledge of the Monitoring Process
- Look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
- Good in handling crisis situations
- Strong problem solving, interpersonal, organizational, as well as attention to detail are required
- Strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager
3
Experience For Clinical Research Manager, Assoc.director Resume
- Strong understanding of GCP-ICH, clinical research/operations, site management and metrics
- Experience working with IRB approval processes
- Defines, assists and prioritizes multi-year plan to support clinical research papers, abstracts, publications and presentations for product post-market studies
- Phase I experience
- Demonstrated ability in the leadership of a team of individuals in the ISSC type process activities
- Several years of experience in clinical research processes, preferably within the medical devices field (ideally dental)
- Good knowledge in statistical methods (parametric as well as non-parametric
- Experience in clinical trial planning and conduct and project management
- Experience in clinical research in a CRO, pharma or biotech company
4
Experience For Stem Cell & Gene Therapy Clinical Research Manager Resume
- Create evidence to support regulatory submissions and to help market our products domestically and internationally
- Good ability to learn and to adapt to work with IT systems
- Previous supervisory or management experience in academic health care setting on topics related to clinical research
- Experience in Research/Healthcare related field
- Experience in pharmaceutical or healthcare industry
- Experience with managing clinical data entry and capture in a research setting
- Dentistry knowledge and strong scientific understanding to face complex problems and identify adequate solutions with a cross functional impact
5
Experience For Asst Clinical Research Manager Resume
- Experience training others on topics related to clinical research conduct and management
- Strong knowledge on drug development, clinical research operations and regulatory requirements
- 2) Support the direct report to build up and maintain good relationships with study sites and internal customers
- Acting as a point-person for researching, reconciling and reporting discrepancies/issues between our site and the central programmatic departments
- Searching/ identifying/compiling of business and product relevant scientific literature incl. writing of reports
- Scheduling and completing post-treatment clinical assessments with suicidal participants and their partners via telephone and web-conferencing
- Performing study initiation’s visits, site monitoring and training
6
Experience For Site Clinical Research Manager Resume
- Coordinating with the collaborating research site in Salt Lake City, Utah
- Supervising undergraduate research assistants in clinical interviewing
- Supervising and coordinating daily research assistants’ research projects, tasks, and responsibilities
- Onboarding new research assistants, including student research assistants
- Reviewing for approval and tracking research assistants time off requests
- Understanding of local / country and regional requirements for clinical trials
- Working knowledge of various databases, Medidata, CRDB, InForm, Tao etc
7
Experience For Clinical Research Manager Gastrointestinal Service Resume
- Monitoring clinical trial procedures
- Overseeing programmatic and institution-specific SOP processes
- Leading weekly group and individual research assistant meetings
- Assisting Principal Investigator and Sr. Program Manager as needed
- Working knowledge of Word, Excel is required
- Understanding of regulatory compliance as it relates to conducting the Study at University of Florida
- Understanding of inherited muscle diseases, which lead to heart and skeletal muscle dysfunction
8
Experience For Clinical Research Manager Thoracic Medicine Resume
- Manages the overall planning, scheduling, budgeting and monitoring of individual clinical research projects from initiation to project closeout
- Provides leadership for planning, scheduling, delivering and maintaining program(s)/project(s) to sustain quality instruction in all educational activity
- Human resources efforts devoted to posting, interviewing, hiring, and onboarding of new staff
- Responsible for building, developing and leading the Clinical Research function at one Medtronic location
- Management of non-therapeutic portfolio assessment and structuring of portfolio, identifying areas of strength/growth and seeking out new opportunities
9
Experience For Assistant Clinical Research Manager Resume
- Design models that leverage the latest technological advancements (i.e data collection strategies document signing, adaptive testing, web-based consenting)
- Partners with CRO Director and the centralized training and education core with overall responsible for the hiring and training of new staff
- Works closely with hospital clinical staff, particularly Nursing Services and Pharmacy to educate staff regarding clinical research studies
- Facilitate the researchers and research coordinators in registering and enrolling all of the active studies into the EHR
- Oversee Clinical Research review of training materials, external communications, and marketing collateral for current and future product lines
10
Experience For Clinical Research Manager Subspecialty Medicine Resume
- Assists Sr. Manager or Associate Dir. in identifying and generating changes in scope within the ISSC activities
- Assist the clinical team in the implementation of clinical projects by gathering information concerning the therapeutic area under investigation
- Essential document monitoring, maintenance, regulatory compliance, approvals, and reporting
- Partner with several global cross functional teams, including Regulatory Affairs, Research and Development, Marketing, and Legal and Compliance
- To record the data from case record forms, review the study material, and visit participating clinics for monitoring
- Participate in reviewing of marketing material with respect to clinical data
- Contribute to the planning and set-up of a study and provide planning parameters , Support early access programs on the country level
- Maintain currency in field through cross training, continuing education, literature and seminars and implement this knowledge into the department
List of Typical Skills For a Clinical Research Manager Resume
1
Skills For Senior Clinical Research Manager Resume
- Strong leadership skills (scientific and business) and proven ability to coordinate and
- Analytical skills, quick perception and good judgment
- Excellent skills in oral and written English
- Strong communication, educational/pedagogic and diplomatic skills
- Strong leadership skills. Knowledge in Site Management
2
Skills For Oncology Clinical Research Manager Resume
- Demonstrated managerial experience; such as two or more years of supervisory experience
- Strong communication, educational / pedagogic, diplomatic and empathic skills
- Extensive experience in the (international) pharmaceutical / medical field with solid clinical trial management / monitoring experience required
- Strong conflict resolution, change management and negotiation skills are required
- Ttraining and mentoring skills
3
Skills For Clinical Research Manager, Assoc.director Resume
- Two years demonstrated experience leading, supervising, or training
- Demonstrated experience in providing work direction and assisting supervisor in maintaining an efficient medical research team
- Analytical, strategical, problem solving skills, out-of-the box thinking
- Demonstrated experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement
- Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement
- Proven succesful interaction with regulatory authorities/ Experience of managing
- Experience in conducting clinical trials as CRA and/or Trial company , with two years’ experience with people management
- The ability to cope and work effectively within an environment that has quickly changing processes and procedures
- MD or PhD or equivalent dgree + 3-6 years of relevant working experience, or at least 10 years of experience in clinical research
4
Skills For Stem Cell & Gene Therapy Clinical Research Manager Resume
- Strong experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures
- Prior on-site monitoring experience
- Assess, prioritize, and process multiple priorities in a fast paced work setting
- A proven record of successful project management and the ability to motivate others to adopt effective practices
- Work effectively and compassionately with individuals with autism
5
Skills For Asst Clinical Research Manager Resume
- Highly organized, reliable, and able to manage time effectively
- Self-motivated to learn new skills and take on new tasks
- Medical Device Experience (2+ years experience)
- Effectively manage study budgets in excess of 10million
- Experience in clinical research execution, include at least 2 years project management experience
6
Skills For Site Clinical Research Manager Resume
- Proficient skills in using software applications such as Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and Adobe Acrobat
- Proven management experience running high-performance cross-functional teams to achieve trial, individual and team goals and objectives
- Six years clinical trials research experience which includes previous project management or leadership experience
- Solid experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures
- Proven experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures
7
Skills For Clinical Research Manager Gastrointestinal Service Resume
- Demonstrated experience working with FDA policies regulating clinical trials
- Clinical research experience essential. People management experience possible but not required
- Five years of prior clinical research coordination experience required
- Strong experience in Oncology
- Communicates effectively to supervisor
- Applies critical thinking skills and utilizes quality data and conceptual knowledge in the development of the department vision and operational plan
- Prior supervisory or project management experience required
8
Skills For Clinical Research Manager Thoracic Medicine Resume
- Proven experience in all aspects of clinical trial management
- Excellent ability to prioritise and handle multiple tasks
- Training and experience in monitoring of clinical trials
- An experience of at least 3 years in Research –including protocol writing, IRB submissions, planning and executing studies according to GCP
- Experience in teaching, precepting and mentoring employees to clinical research
- Experience in leading or developing people
9
Skills For Assistant Clinical Research Manager Resume
- Experience mentoring/coaching others
- Strong scientific and clinical knowledge, an understanding of clinical trial planning and management
- Relevant of experience in clinical Research, including monitoring and project management
- Experience coordinating and leading teams to high performance
- Good understanding of questions regarding dentistry
- Good understanding of the Study Drug Handling Process and the Data Management Process
10
Skills For Clinical Research Manager Subspecialty Medicine Resume
- Excellent ability in working according to global standards
- Experience in conducting studies for Regulatory Agencies
- Proven record for leading teams to define strategy and deliver work programs to enable a business unit achieve its business goals
- Solid background local regulation & leading Clinical Trials teams
- Assure excellent conduct of research by providing expertise for faculty and oversight for research staff (direct reports)
- ´s of experience in Cinical Research for a MS/MBA/JD, including 5 years as CRA
- ´s of experience in Clinical Researchfor an MD-PhD, including 3 years as CRA
- Proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment
- Excellent working knowledge of the CFR GCP
List of Typical Responsibilities For a Clinical Research Manager Resume
1
Responsibilities For Senior Clinical Research Manager Resume
- Training and experience in monitoring and managing small, manual tracking clinical trials
- Complete design validation reports and maintaining study-related databases
- Previous grant writing experience
- Experience in a medical group setting
- Relevant experience, particularly with neuroimaging and related protocols
- Experience in clinical trial planning and conduct
- Experience with negotiating with both internal and external group
- Excellent communication, both verbally and in writing
2
Responsibilities For Oncology Clinical Research Manager Resume
- Experience running multi-site behavioral research clinical trials
- Relevant experience, preferably in an academic or clinical setting
- Ensures appropriate resources and priorities are maintained for the assigned projects
- Leading & Coaching
- Understanding of clinical trial regulations across multiple regions
- Comfortable working closely with a team taking ownership/initiative where needed, and taking/delegating tasks
3
Responsibilities For Clinical Research Manager, Assoc.director Resume
- Participates in the research and academic activities including departmental strategic planning
- Develop other team members through mentoring and coaching in complex subjects
- Track, review and prepare study-specific information utilizing databases, spreadsheets, and other tools for reporting status updates to the team
- Communicate the Clinical Strategy to all levels in the company, including Senior Leadership Team, R&D, Regulatory and Marketing groups
- Contribute to the reviewing and updating of all procedures within the department
4
Responsibilities For Stem Cell & Gene Therapy Clinical Research Manager Resume
- Assist in developing and implementing clinical research trials for department
- 4) Provide training and guidance to junior team members and business partners
- Communicates and presents study results and program issues to project team and other key internal stakeholders (development, marketing, operations, etc.)
- Monitors compliance with all FDA and applicable regulations concerning clinical activities
- Interaction with Sponsors/CROs, IRBs, patients/subjects, nursing and medical staff of various clinics, hospitals and physicians’ offices
- Managing staff
- Provide support staffing models, mentorship, and program development for the Prevention and Control group
- Provide oversight and quality assurance of regulatory and budgeting/finance components of the portfolio
5
Responsibilities For Asst Clinical Research Manager Resume
- Ensures high quality of service provided by local vendors, e.g. local drug depot, printing, medical translation and external legal counsel
- Conducts post-marketing studies
- Recommend improvements, policies, and procedures related to conducting research and associated functions
- Deliver quality according to the requested standards
- Meet regularly with Research Institute business office and finance personnel regarding study budgets, income, and expenses
- Ensure successful conduct of GBU clinical programs consistent with R&D and Marketing plans and applicable regulations and policies
6
Responsibilities For Site Clinical Research Manager Resume
- Works well both within a team setting and independently
- Opportunity to provide immediate impact on a small but growing team
- Provide strategic direction on how to best streamline our process and procedures given changing global regulations
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned
- Responsible for the budget, site selection, resource planning and trial submission process of international studies in the specific area
- Basic knowledge of clinical development processes, including related functional areas outside of Clinical
7
Responsibilities For Clinical Research Manager Gastrointestinal Service Resume
- Expertise managing single-site, large, federally or nationally-funded behavioral research clinical trial
- Industry Training and/or certifications (e.g., ACRP, SoCRA CCRP)
- Manage staff objective setting, regular communication and feedback, development activities and appropriate reward and recognition programs
- Knowledge of cost accounting as applied to both University and Medical Center functions
- Deep understanding of clinical techniques for PK/PD, exposure and individual and population risk assessment
- Prepares reports to the sponsoring institution
8
Responsibilities For Clinical Research Manager Thoracic Medicine Resume
- Multi-task and manage several projects in parallel paying attention to detail
- Forge cross- functional working relationships with internal teams and external project partners
- Provides detailed reporting on study finances
- 1) People development for direct reports, perform performance review with direct reports, discuss and approve development plan for direct reports
- 2) Overview project management quality and process for direct reports; Support direct reports on project management and site management
- 3) Review clinical research SOP and provide input on SOP revision
- Responsible for team’s interface and collaboration with key opinion leaders, investigators, clinical institutions, Regulatory Agencies, societies, associations
9
Responsibilities For Assistant Clinical Research Manager Resume
- Manage and oversee the activities of CROs and other operational contractors and third parties involved in the conduct of CH studies. This includes that the incumbent ensures that all applicable guidance’s including, however not limited to ICH Guidelines, GCP and SOPs are followed in all aspects of the studies
- Participates on product development teams as clinical representative
- Monitors or ensures adequate oversight of study is conducted
- Creates, improves and implements departmental procedures and clinical trial documents
- Manages clinical development budget within stated financial goals
- Oversees the internal and external audit programs for clinical studies
- Evaluates clinical data/information and writes reports, abstracts and papers as required
- Previous human subjects training (e.g., CITI certification) and four years’ experience in clinical research with direct recruitment and enrollment responsibilities
10
Responsibilities For Clinical Research Manager Subspecialty Medicine Resume
- Clinical research experience
- Direct staff management
- Thorough knowledge of Good Clinical Practice (GCP) guidelines, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process required
- Effective written/verbal communication and oral presentation skills required. Excellent interpersonal, leadership, decision-making and issue resolution skills are also required
- Working knowledge of various databases, RedCap, Medidata, CRDB, Access, etc
- Familiarity with Non-therapeutic protocols, including Biospecimen, Retrospective and PRO studies
- Familiarity with grant application process
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