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Become A Clinical Study Manager

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Working As A Clinical Study Manager

  • Getting Information
  • Establishing and Maintaining Interpersonal Relationships
  • Making Decisions and Solving Problems
  • Organizing, Planning, and Prioritizing Work
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $97,552

    Average Salary

What Does A Clinical Study Manager Do At Regeneron Pharmaceuticals

* Organizes and delivers analyzable reports and metrics to the clinical study leader
* Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
* Collates data for assessments such as feasibility and site selection and reviews site usability database
* Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
* Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
* Collates materials for training and investigator meetings
* Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
* Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
* Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study leader guidance
* Ensures scheduled reports are received (i.e. reportable changes, financial disclosure form)
* Manages and maintains team SharePoint and/or shared drive sites, as needed
* Communication with sites as directed and maintains site contact information
* Contributes to line listings review for Blind Data Review Meeting (BDRM)
* May manage or contribute to oversight of Third Party Vendors (TPV)
* Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
* Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
* Proactively recommends process improvement initiatives for the department

What Does A Clinical Study Manager Do At Covance

* Accountable for execution and oversight of local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally
* Ownership of country and site budgets; development, negotiation and completion of Clinical Trial Research Agreements; oversight and tracking of clinical research-related payments; payment reconciliation at study close-out; oversight and maintenance of financial systems
* Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols; development of local language materials including local language Informed Consents and translations; interactions with IRB/IEC and Regulatory Authority for assigned protocols
* Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments; responsible for quality and compliance in assigned protocols in country; contribution to the development of local SOPs; overseeing Clinical Trial Coordinators as applicable
* Coordinates and liaises with Country Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones; collaborates closely with Regional Operations to align country timelines for assigned protocols
* Oversight and coordination of local processes; clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management; enters and updates country information in clinical systems

What Does A Clinical Study Manager Do At Washington University of St. Louis

* Assists in protocol development, budget development, dispensing of study funds for multi-clinical research projects; provides high level of direct and indirect support direct
* Works with PI to design, perform, and evaluate research procedures; confers with PI to assist in developing plans for research projects and discuss the interpretation of results; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate
* Serves as a resource to the clinical research staff, ensuring appropriate procedures, and explains policies and procedures; ensures that research projects are completed according to IRB and federal guidelines
* Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in the hiring, training, and evaluation of clinical research staff
* Provides Study Coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols
* Researches and recommends new methods and procedures to maintain standards and improve quality
* Responsible for ensuring a highly coordinated approach to the participant recruitment efforts of multicenter clinical trials being conducted at the University.
* Develops a plan to implement informatics elements are well-integrated with the human effort-driven dimensions of the recruitment equation.
* Trains recruitment specialists that can interface effectively with study teams, and will ensure the execution of strong study-specific recruitment plan in accordance with study protocols and regulatory approvals

What Does A Clinical Study Manager Do At Advanced Clinical

* Clinical project management of a clinical study (or studies) Create and drive study level timeline Assist with the collection of feasibility data to develop the enrollment Assist with study budget issues, as assigned Ensure regulatory compliance and GCP compliance Responsible for oversight of TMF with periodic audits Contribute to vendor selection and management including issue escalation Support with developing and managing study plans (including but not limited to Study Management Plan, Vendor Oversight Plan, Compliance Plan, TMF plan) and all associated documents Collaborate with CTS team to plan and coordinate IMP and non
* IMP supplies Lend support to SET internal meetings Assist with development and execution of monitoring plan and monitoring oversight plan in collaboration with CPM and Site Management (COMs) Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs Consult with COMs for strategic selection of countries and sites Ensure SET team and external partner(s) receive and document study specific training Report key study performance information, including study start-up metrics, enrollment, data collection, timeliness/quality Facilitate study close out activities through completion of Clinical Study Report Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations Ensure standard processes, tools and procedures are used consistently for study execution Ensure complete and timely IMPACT updates Support regulatory submissions Review country/site ICF Support audits/inspections and resolution of findings Track contract execution and assist in resolution of site issues in partnership with Site Management and COMs Support IMP management

What Does A Clinical Study Manager Do At Astellas Pharma

* Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
* Manage and lead cross-functional study teams, including vendors
* Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
* Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
* Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data
* Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
* Lead feasibility assessment and selection of countries and sites for study conduct
* Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
* Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
* Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct
* Provide oversight and direction to study team members for study deliverables; may provide direction to Clinical Study Managers, Associate Clinical Study Managers and Clinical Trial Associates for assigned studies
* Quantitative Dimensions:
* Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies.
* Responsible for study budgets up to $100M.
* Organizational Context:
* Reports to the Senior Manager, Clinical Study Management or above.
* This position has no direct reports but may provide oversight and direction to study team members for study deliverables and may provide supervision to Clinical Study Managers, Associate Clinical Study Managers and Clinical Trial Associates

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How To Become A Clinical Study Manager

Natural sciences managers usually advance to management positions after years of employment as scientists. Natural sciences managers typically have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a related field, such as engineering. Some managers may find it helpful to have an advanced management degree—for example, a Professional Science Master’s (PSM) degree, a Master of Business Administration (MBA), or a Master of Public Administration (MPA).

Education

Natural sciences managers typically begin their careers as scientists; therefore, most have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a closely related field, such as engineering. Scientific and technical knowledge is essential for managers because they must be able to understand the work of their subordinates and provide technical assistance when needed. 

Natural sciences managers who are interested in acquiring postsecondary education in management should be able to find master’s degree or Ph.D. programs in a natural science that incorporate business management courses. A relatively new type of degree, called the Professional Science Master’s (PSM), blends advanced training in a particular science field with business skills, such as communications and program management, and policy. Those interested in acquiring general management skills may pursue a Master of Business Administration (MBA) or a Master of Public Administration (MPA). Some natural sciences managers will have studied psychology or some other management-related field to enter this occupation.

Sciences managers must continually upgrade their knowledge because of the rapid growth of scientific developments.

Work Experience in a Related Occupation

Natural sciences managers usually advance to management positions after years of employment as scientists. While employed as scientists, they typically are given more responsibility and independence in their work as they gain experience. Eventually, they may lead research teams and have control over the direction and content of projects before being promoted to an administrative position.

Licenses, Certifications, and Registrations

Although certification is not typically required to become a natural sciences manager, many relevant certifications are available. These certifications range from those related to specific scientific areas of study or practice, such as laboratory animal management, to general management topics, such as project management, and are useful to natural sciences managers regardless of the organization being managed.

Important Qualities

Communication skills. Natural sciences managers must be able to communicate clearly to a variety of audiences, such as scientists, policymakers, and the public. Both written and oral communication are important.

Critical-thinking skills. Natural sciences managers must carefully evaluate the work of others. They must determine if their staff’s methods and results are based on sound science.

Interpersonal skills. Natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals. Managers routinely deal with conflict, which they must be able to turn into positive outcomes for their organization.

Leadership skills. Natural sciences managers must be able to organize, direct, and motivate others. They need to identify the strengths and weaknesses of their workers and create an environment in which the workers can succeed.

Problem-solving skills. Natural sciences managers use scientific observation and analysis to find solutions to complex technical questions.

Time-management skills. Natural sciences managers must be able to do multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule.

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Clinical Study Manager jobs

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Real Clinical Study Manager Salaries

Job Title Company Location Start Date Salary
Study Manager Inventiv Health Clinical SRE LLC Cambridge, MA Sep 11, 2015 $147,680
Clinical Study Manager Randstad Professionals Us, LP Northbrook, IL Aug 15, 2016 $146,090
Study Manager On Assignment, Inc. Indianapolis, IN Sep 10, 2015 $145,600
Clinical Study Manager Randstad Professionals Us, LP Northbrook, IL Apr 01, 2016 $135,655
Clinical Study Manager Randstad Professionals Us, LP Northbrook, IL Jul 20, 2015 $135,655
Clinical Study Manager Smith Hanley Consulting Group, LLC Collegeville, PA Sep 07, 2012 $135,655
Study Manager Smith Hanley Consulting Group LLC Collegeville, PA Mar 09, 2011 $135,655
Clinical Study Manager Smith Hanley Consulting Group, LLC Edison, NJ Oct 31, 2011 $135,200
Study Manager-Paritosh Lamba Inventiv Health Clinical, LLC Davie, FL Jul 18, 2016 $130,000
Manager, Study Endpoints Ironwood Pharmaceuticals, Inc. Cambridge, MA Jun 09, 2016 $110,000
Clinical Research Study Manager Amgen Inc. Thousand Oaks, CA Jun 29, 2014 $103,674
Clinical Research Study Manager Amgen Inc. Sanford, FL Oct 11, 2010 $99,480
Senior Clinical Study Manager, Global Clinical Operations Eisai, Inc. Woodcliff Lake, NJ Sep 19, 2016 $97,552 -
$128,000
Clinical Research Study Manager Amgen Inc. Thousand Oaks, CA Mar 15, 2010 $95,134
Senior Clinical Study Manager Takeda Global Research & Development Center, Inc. Deerfield, IL Jul 01, 2013 $95,000 -
$105,000
Clinical Study Manager Integrated Resources, Inc. Woodcliff Lake, NJ Feb 05, 2016 $93,915
Clinical Study Biostatistician Chicago Association for Research and Education In IL Aug 15, 2011 $85,176
Clinical Study Manager Alcon Research, Ltd. Fort Worth, TX Aug 24, 2012 $81,000 -
$101,000
Clinical Study Manager Alcon Research, Ltd. Fort Worth, TX Aug 24, 2009 $81,000 -
$91,000

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Top Skills for A Clinical Study Manager

StudyProtocolClinicalStudyReportsClinicalTrialRegulatoryDocumentsCROProceduresIRBCRACRFDataManagementSafetyOversightFDAPhaseIIIInvestigatorMeetingsStudyBudgetClose-OutDataCollectionOncologyStudyStart-UpActivities

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Top Clinical Study Manager Skills

  1. Study Protocol
  2. Clinical Study Reports
  3. Clinical Trial
You can check out examples of real life uses of top skills on resumes here:
  • Developed study protocol, informed consent, study advertisements, and sections of clinical study report.
  • Authored clinical study reports, abstracts.
  • Participated in the validation process of all tools utilized to capture and manage clinical trial data.
  • Obtained regulatory documents from three sites within six weeks of pre-study visit by using successful communication and motivational skills.
  • Partnered with the Study Managers to develop high performing cross-functional Clinical Study Teams.

Top Clinical Study Manager Employers