Clinical Study Manager Resume Sample
Willa Hills
7663 Zboncak Mission,
New York,
NY
+1 (555) 554 2156
Work Experience
Clinical Study Manager
05/2016
-
PRESENT
Dallas, TX
- Leads the clinical project plan, including study budget. Writes and develops the protocol, informed consent and other study specific documents
- Manages the development of the clinical site training materials; Plans the investigator meetings. Manages site nomination, qualification, and selection process. Conducts on-site monitoring and study closeout visits, writes reports and site correspondence, co-monitors (trains and evaluates) other CRA's and CSC's
- Designs, develops, and tests the CRFs and databases in collaboration with the study data manager
- Determines contract service needs and negotiates site and vendor contracts in collaboration with legal department and assists with vendor selection
- Manages site regulatory submission and approval process. Responsible for country regulatory submission and approval internally or with vendor. Collects, files and tracks site regulatory documents
- Contributes to ongoing SOP review and development
- Manages the establishment of the Clinical Central File and ensures proper document control
Senior Clinical Study Manager
02/2011
-
03/2016
Phoenix, AZ
- Performs periodic audits of clinical study files for completeness
- Responsible for writing and development of the protocol, informed consent, and other study-specific documents
- Responsible for the clinical project plan; including overall study budget
- Manages development the clinical site training materials; responsible for planning the investigator meetings
- Responsible for the design, development and testing of the CRFs and databases in collaboration with the study data manager
- Responsible for determining contract services needs and site and vendor contract negotiation in collaboration with legal departments, assists with vendor selection
- Responsible for Collection, filing, and tracking of site regulatory documents
- Manages site regulatory submission and approval process. Responsible for country regulatory submission and approval internally or with vendor
Global Clinical Study Manager
04/2008
-
01/2011
Detroit, MI
- Responsible for negotiation of site contracts and budgets; responsible for study budgets and accruals; clinical site training; study data and database function in collaboration with the study data manager
- Responsible for site monitoring; Conducts on-site monitoring and study closeout visits, writes reports and site correspondence, co-monitors (trains and evaluates) other Tornier CRA's and CSC's
- Contribute to departmental regular meetings for project update and review
- Experience directly supporting clinical research or similar experience in a medical/scientific area
- Provide clinical operations support in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites
- Supervise clinical team to ensure all study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs
- Provide ongoing assessment, evaluation, and communication with other Avanir departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives are accomplished
Education
Grand View University
2003 - 2007
Bachelor's Degree in Life Sciences
Professional Skills
- Excellent interpersonal skills, proven people management skills with demonstrated good expertise in team work
- Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills
- Excellent communication skills in English and solid influencing skills to interact with internal and external stakeholders
- Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives
- Time management skills – ability to effectively prioritize
- Demonstrated strong negotiation and conflict resolution skills both internal and external (site relationships)
- Strong negotiation and professional communication skills - strong oral and written English
How to write Clinical Study Manager Resume
Clinical Study Manager role is responsible for interpersonal, negotiation, microsoft, english, leadership, excel, software, languages, medical, word.
To write great resume for clinical study manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Study Manager Resume
The section contact information is important in your clinical study 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 Study Manager Resume
The section work experience is an essential part of your clinical study 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 study 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 study manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Study Manager resume experience can include:
- Experience in clinical research or having demonstrated adequate level of proficiency within the CRA III competency profile
- Solid understanding of clinical trial design, trial execution and operations
- Expertise in communication, managing multiple priorities and computer literacy
- Managing the study budget according to finance metrics and approving the country study budget allocation
- Ensuring distribution of all safety updates to EC and sites
- Leading the UK/RoI Clinical Trial Team of assigned trials
Education on a Clinical Study Manager Resume
Make sure to make education a priority on your clinical study 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 study 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 Study Manager Resume
When listing skills on your clinical study 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 study manager skills:
- Handle complex projects, and demonstrates flexibility in managing changing priorities, strategic problem solving and judgment skills
- Demonstrate good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information
- Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences
- Strong technical writing skills and a basic understanding of medical /clinical terminology
- Study Management/Project Management skills - demonstrates understanding and quality delivery of study milestones according to established timelines
- Leadership / influence management skills including stakeholder management and effective communication
List of Typical Experience For a Clinical Study Manager Resume
1
Experience For Senior Clinical Study Manager Resume
- Good communication skills (both oral and written) and able to work effectively in cross-functional teams both internally and externally to the organization
- Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment
- Proven good negotiation skills
- Excellent time management skills & project management experience
- Demonstrated interpersonal, written and oral communication as well as organizational planning skills
- Strong negotiation and professional communication skills
2
Experience For Lead Clinical Study Manager Resume
- Good interpersonal skills with the ability to build and enhance relationships with CRO study teams
- Excellent team leadership, motivation and interpersonal skills
- Demonstrated interpersonal, written and oral communication skills
- Understanding of regulatory document creation and review; Proficiency in Microsoft office products and professional writing skills
- Related experience in the pharmaceutical/biotechnology industry, including 2+ years of management experience
- Developed influencing skills
- Experience in the Pharmaceutical Industry; 3+ years of experience as a Regional Manager
3
Experience For Clinical Study Manager Oncology Resume
- Study management / Project management skills
- Ideally experience of working with health care economist teams or at least a good understanding of the link between the two areas
- Exceptional organizational, interpersonal, management and oral communication skills
- Effectively lead and direct a global cross-functional team in a matrix environment
- Communication skills both written and verbal that allow them to express themselves clearly and articulately within different cultural environments
- Build and maintain excellent working relationships with KOLs and colleagues
- Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management
- Skilled in working in cross-functional, virtual and international teams
4
Experience For Global Clinical Study Manager Resume
- Experience in supporting the execution of global clinical trials (pharmaceutical or research institute)
- Experience in the pharmaceutical/biotechnology industry
- Tertiary qualifications in life sciences or related field or equivalent education and experience
- Experience in managing communications with external vendors
- In depth and up to date knowledge of Good Clinical Practice and other regulatory standards (e.g. ISO 14155)
- Maintaining a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
5
Experience For Senior Global Clinical Study Manager Resume
- Experience in CNS (ideally Epilepsy) therapeutic area
- Experience in clinical research in the pharmaceutical industry
- Experience in clinical trials in the medical device, pharmaceutical, or tobacco industry
- Relevant experience Study Management Team Leader - Oncology is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD
- Pharmaceutical industry and scientific/medical affairs experience is required
- Person needs to be comfortable with global team and strong relationship builder
6
Experience For Clinical Study Manager, Based Resume
- Direct clinical research experience in the medical device, consumer product, pharmaceutical, or other related industry
- Able to interpret scientific data and skilled in the use of computerized systems and databases
- Experience as a Clinical Research Associate, Clinical Project Manager or equivalent external position
- Demonstrated knowledge and application of personal computer systems and desktop applications
- Relevant experience is required with a BS, 2 years with a MS/MPH, or 1 year with PharmD/PhD/MD
- Understanding of budget forecasting and management
- Planning evaluation and selection of clinical studies sites/investigators
- Looking for study manager to execute existing global PD study
7
Experience For Principal Clinical Study Manager Resume
- Responsible for establishing and maintaining External Service Provider(s) relationships, providing performance management as necessary
- Takes the lead and/or overall coordination of all required start-up activities including, but not limited to, the following
- Chairs operations team meeting and organizes investigator meetings, monitor training, CRO kick-off meetings
- Ensure appropriate training is achieved at Investigator Meeting
- Subject matter expertise in understanding all aspects of clinical drug development with particular emphasis on monitoring and study execution
8
Experience For Clinical Study Manager Resume
- Review monitoring reports according with the applicable procedures
- Develop action plan as a response to an audit/inspection report, ensuring the monitoring of corrective and preventive actions indicated in the report
- Participates in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings)
- Independently monitor and/or oversee monitoring by CRAs, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew procedures
- Serves as a Study Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
- Study execution and status reporting activities
- MS Project or similar project planning and management software is desirable
- Responsible for/contribute to vendor selection and management including issue escalation
9
Experience For Senior Clinical Study Manager Resume
- Contribute to vendor selection and management including issue escalation
- Help to ensure SET and external partner(s) receive and document study specific training
- Leads identification and selection of vendors (participating in the Request for Proposal [RFP] process), in collaboration with CPL
- Conducts protocol, and site feasibility assessments; partnering with CPL on final site selection
- Oversees all activities related to site selection, contracting, set-up and maintenance
- Primary interface in North America for clinical sites and cross-functional project teams ensuring study execution is on-time and within budget
10
Experience For Lead Clinical Study Manager Resume
- Clinical Trial delivery in accordance with KPI and KQI, as well as ensuring its compliance with Novartis SOP/WP and ICH-GCP guidelines
- Support and coordinate feasibilities of new studies to be conducted in UK/RoI and leading centre selection
- Liaise with Regulatory Affairs to ensure that all RA approvals are granted in a timely manner. -Responsible for submitting studies to EC and R&D
- Provides training and support to other members of the teams
- Responsible to execute and/or support the following activities to ensure study delivery
- Ensures that reporting process of SUSARs is established and maintained for the duration of the study
- Ensures the completion and finalization of any corrective and preventative action plans resulting from site audits, in conjunction with CCO, etc., as necessary
- Provides operational input into the development and tracking of SMT goals
List of Typical Skills For a Clinical Study Manager Resume
1
Skills For Senior Clinical Study Manager Resume
- Experience managing projects, strong project management skills are needed
- Handle complex projects, prepare risk management plans and demonstrates problem solving skills
- Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint
- Proven leadership experience and strong collaborative communications with External Service Provider(s)
- Experience from leading trial teams and experience leading remote teams is an advantage
2
Skills For Lead Clinical Study Manager Resume
- Project management skills including meeting facilitation
- Proven experience in monitoring or managing oncology clinical trials (min. 2-3 years)
- Study Tools including electronic system skills – CTMS / EDC/eTMF, etc
- Fluent business English (oral and written) and basic medical writing skills
- Proven experience in the medical device industry within a clinical setting or research field, ideally in similar position
- Responsible for measurement and reporting of key performance indicators that efficiently and effectively monitor key aspects of study performance
- Advanced negotiation and written and verbal communication skills in English
- Communicates effectively in a local/global matrixed environment
3
Skills For Clinical Study Manager Oncology Resume
- Proven project management delivery and demonstrated ability to manage multiple deliverables
- Effectively manage multiple deliverables simultaneously
- Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report
- Create appropriate study related training for monitors and site personnel according to Good Clinical Practices (GCP) and company standards
- Project management experience (specifically leading) within the context of clinical development (including scope, budget, timeline)
4
Skills For Global Clinical Study Manager Resume
- Experienced in working within a Matrix Environment
- Previous experience performing Clinical Operations functions
- Experienced working in Clinical Research in a Study Management capacity
- Demonstrated working knowledge of the principles of drug and device development
- Experience in nursing, or medical devices/pharmaceutical industry
- Experience managing clinical research studies
- Demonstrated ability to understanding and interpret clinical data and literature
5
Skills For Senior Global Clinical Study Manager Resume
- Successful experience working with global cross-functional teams across multiple work locations
- Demonstrate operational expertise in risk management and contingency planning
- Responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies
- Demonstrated ability to lead teams and work in a fast-paced team environment
- Trained to think strategically and experienced in clinical study methodology
- Experience in identification of sites and investigators
- Give valid interpretations and any limitations from past data
6
Skills For Clinical Study Manager, Based Resume
- Experience in (international) clinical study management
- Experience in (international) clinical study management (i.e. lead CRA, senior CRA, Clinical Study Manager)
- Previous HIV experience would be preferable but is not essential
- Significant Study Management experience is essential
- Extensive experience in (international) clinical research
- Work with other members of organization and External Service Provider(s) to share knowledge, experiences and best practices
7
Skills For Principal Clinical Study Manager Resume
- Demonstrate an extensive knowledge of clinical study and drug development process, GCP/ICH guidelines and SOPs
- Proven ability to drive performance and delivery through internal and external partners
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
- Motivating financial remuneration & numerous employee benefits
- Supervises the interface with data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
8
Skills For Clinical Study Manager Resume
- Assist with development and execution of monitoring plan and monitoring oversight plan in collaboration with CPM and Site Management (COMs)
- Provides critical thinking and leadership when issues arise during execution of clinical studies
- Ensure posting of assigned local studies to clinicaltrials.gov, including final publication of results
- Provide critical thinking and leadership when issues arise during execution of clinical studies
- Participate in the analysis, summary, and reporting of clinical data for regulatory, marketing, or other purposes
- Perform initiation, monitoring, and close-out visits and provide monitoring visit reports
- Provide oversight and review of monitoring visit reports ensuring the team meets required timelines for review and submission
- Provides leadership in identifying operational risks and developing mitigation and contingency plans
9
Skills For Senior Clinical Study Manager Resume
- Provide training as needed for monitors and any other activities that
- Data cleaning process is successfully accomplished within the required timelines in the country/group of countries
- Identify staff training needs and facilitate access to it
- Interested in developing a wider knowledge of clinical trial regulations across different EU countries
- Proficient understanding of clinical trial and data management processes
- Capable of leading in a matrix environment, without direct reports
- Develop, with stakeholders, the total external study budget, monthly/yearly estimates, and plans for resolving study finance issues
- Versatile and fulfilling role in a dynamic and international corporation
- Product and indication/disease knowledge, understanding basics of surgical procedures
10
Skills For Lead Clinical Study Manager Resume
- Capable of working within in a matrix environment, without direct reports
- Performs/Oversees Study Management activities including but not limited to Protocol development
- Oversees site selection and training
- Perform and supervise site initiation, management and monitoring
- Serves as a Clinical Study Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
- Manages relationships with sites/PIs. other study related vendors, including CRO’s
- Perform review of clinical reports by utilizing protocol and
- Provide status updates regarding projects to clients and other departments
List of Typical Responsibilities For a Clinical Study Manager Resume
1
Responsibilities For Senior Clinical Study Manager Resume
- Have experience with coaching people or managing a team
- Experience in mentoring of health care workers on research studies conduct
- Manages overall study budget(s), ensuring efficient expenditure and minimizing variance between actual and forecasted spend
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Establishes study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections
- Full autonomy for driving key/strategic study-related decisions, managing vendors and stakeholders by influence in a dynamic environment
- Maintains high performing teams
- Monitor changes in FDA and Health Canada regulations and implement into internal standard operating procedures
2
Responsibilities For Lead Clinical Study Manager Resume
- Serve as a Study Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
- Manage pre-defined study timelines and be proactive in identifying delays and possible solutions to meet deadlines
- Participate in regulatory agency inspections and client audits as well as the ensuing response process
- Coordinate study monitoring visits
- Participate in the training of colleagues
- Lead the study specific activities during the setup, conduct and close-out of studies for different Health Relief and Health Wellness RB brands
- Develops and maintains current program level training materials
- Provides program-level reporting to management
3
Responsibilities For Clinical Study Manager Oncology Resume
- Ensure Sponsor oversight by overseeing the progress of studies and performance of ESPs on a continual basis
- Provide progress reporting (resources, budgets, timelines)
- Coordinate monthly Medical Affairs Working Group meetings with global markets
- Works closely with clinical, safety, regulatory, and manufacturing on various tasks to ensure
- Oversee and assess the selection process and ongoing performance of clinical study sites
- Design, develop and write study documents including : protocols, study summaries, PMCF study plans, Informed Consent templates and Case Report Forms (CRFs)
- Oversee Clinical Research Organization (CRO) conduct of monitoring visits, resolve issues and give direction to CRO and sites
- Serve as primary contact between study site personnel and sponsor regarding study-related issues
4
Responsibilities For Global Clinical Study Manager Resume
- Provides feedback about the quality of monitoring activities to CSM Group Head or Sr. CSM as appropriate
- Ensure External Service Provider(s) manage their portfolio of deliverables according to agreed timelines, budget and quality
- Participates in budget management, central service management, and management reporting in a matrixed environment
- Help to ensure SET team and external partner(s) receive and document study specific training
- Capable of leading in a matrix environment, without direct reports, but can coordinate the activities of others
- Learns fast, grasps the essence of our innovative ideas and can translate these into credible, scientific research, changing course when necessary
- Focus on the long term vision and be adaptable to the changing needs of the business
- Ensure that the clinical studies and activities are completed on time and according to the budget
- Coordinate the evaluation, initiating and closeout of sites to ensure compliance with Novartis requirements
5
Responsibilities For Senior Global Clinical Study Manager Resume
- Oversees/leads study-specific study management resources
- Develops and manages programs for an entire business unit or large development program
- Mentors Associates at the Associate Study Manager, Study Manager I and Study Manager 2 levels
- Leaders contribute to continuous improvement activities/initiatives
- Budgets/schedules development (in collaboration with Core Team)
- Obtains, reviews and approves study documents
- Maintains trial master file
- Final clinical study report and study closeout activities
6
Responsibilities For Clinical Study Manager, Based Resume
- Fluent in either Danish, Norwegian or Swedish and fluent in English (oral and written)
- Knowledge of international standards (GCP), international (FDA, EMEA) and local regulations
- Collaborate with CS&L team to plan and coordinate IMP and non-IMP supplies
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
- Assigns and documents study specific roles and responsibilities to internal and external team members
- Consult with COMs for strategic selection of countries and sites
7
Responsibilities For Principal Clinical Study Manager Resume
- Act as the primary point of contact for internal groups outside of CR&D (Regulatory, Commercial Development, and Project Management) for study specific information
- Ensure standard processes, tools and procedures are used consistently for study execution
- Clinical project management of a clinical study (studies)
- Help to create and drive study level timeline
- Assist with the collection of feasibility data to develop the enrollment in close cooperation with site management team and assist with study budget issues, as assigned
- Responsible for oversight of Trial Master File (TMF) with periodic audits
- Support with developing and managing study plans and study specific documents (including but not limited to Study Management Plan, Vendor Oversight Plan, Compliance Plan, TMF plan, country/site ICFs) and all associated documents
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and site management team
8
Responsibilities For Clinical Study Manager Resume
- Support regulatory submissions and contract execution and support audits/inspections and resolution of findings
- Ensure complete and timely IMPACT updates
- Provides operational support at the country and/or above country global level for ISS’s and Collaborative studies and interacts with and supports internal matrix partners and external partners (e.g., GSK staff and vendors)
- Eight or more years’ experience in clinical trial operations with at least 3 years’ experience in the management of complex oncology clinical trials. Previous hematology trial experience and experience with FDA inspections is desirable
- Independently leads one or more complex cross-functional Study Management Teams(s) (SMTs) and/or Supported Research Team(s) (SRTs) through all study stages (start-up, conduct, close-out) to accomplish studies outlined by the medical plan
9
Responsibilities For Senior Clinical Study Manager Resume
- Oversees cross-functional activities and ensures delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply, TMF
- Liaises with cross-functional team members including the SMT/SRT members to solicit input
- Provides guidance, approves and implements study plans including; vendor oversight, risk, quality, safety, communication, TMF
- Oversees EDC and CTMS systems and data maintenance
- Achieves study objectives and milestones within approved timelines, budgets, and resources, under the direction of the Clinical Program Leader (CPL)
- Partners closely with Medical colleagues to provide strategic, operational input on protocol feasibility
- Utilizes outputs from operational analytical tools to enhance and improve study execution
- Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work
10
Responsibilities For Lead Clinical Study Manager Resume
- Partners with Site Contracts on development and finalization of site budget template and budget negotiations
- Responsible for North America clinical projects for device and service laboratories
- Responsible for protocol development and/or review to assure compliance with regulatory requirements and alignment with study objectives
- Responsible for clinical trial conduct at multiple external sites
- Responsible for coordinating with medical facilities and clinical research organizations to support sample acquisition activities for R&D and service laboratory projects
- Initiate, coordinate, and take responsibility for developing supporting documents (such as informed consent, case report forms, etc) related to study conduct, including source documentation, monitoring and study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives
- Conduct remote data monitoring and on-site monitoring visits (training, monitoring, close-out) in accordance with Federal regulations (FDA & Health Canada), Good Clinical Practices, ICH guidelines and standard operating procedures
- Establish professional rapport and frequent communication with investigational site personnel
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