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Become A Clinical Research Manager

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Working As A Clinical Research 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

  • $133,270

    Average Salary

What Does A Clinical Research Manager Do At Merck

* Design and organization of paper and Electronic Data Capture (EDC) clinical studies –irrespective of their complexity - that meet scientific and regulatory requirements.
* This includes the setting of objectives, budgetary aspects, resources, timelines and the study protocol,
* Provide overall leadership and support to the study team.
* Prepare the Study Protocol.
* Make the final selection of the Investigators, laboratories and/or CROs for the study.
* Apply for the necessary study permits and licenses – with support of local regulatory staff and GRA – within the specified study timeline
* Train the study team on the Study Protocol, as appropriate.
* Ensure the timely selection and ordering of (I)VP and CP.
* Ensure compliance of the administrative aspects of the study (budgets and agreements) with the applicable Merck policies and procedures.
* Plan and coordinate the monitoring and data management activities of each study.
* Ensure that the study is conducted according to legal requirements, GCP and the applicable internal policies and procedures.
* Prepare the Final Study Report.
* Maintain contact with the all stakeholders (project leader, RA, Quality Assurance etc.) and keeps them informed of the study progress.
* May be the GCR representative in the project team.
* In addition the CRM:
* Can assume responsibility for certain monitoring and data management tasks (e.g.
* User Acceptance Test of electronic CRFs).
* Can monitor clinical studies under the leadership of other CSTLs.
* Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
* Perform quality control inspections of study protocol, study documentation files and reports as appropriate.
* When required, serves as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities.
* Prepares Efficacy Critical Summaries and expert reports.
* Supervise trainees and provide mentorship and support to other GCR staff as appropriate.
* Supports GRA in the defence of approved products.
* Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
* Conducts post-marketing studies

What Does A Clinical Research Manager Do At Northwestern University

* Technical
* In partnership with Principal Investigators (PIs) provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
* Oversees management of studies including start-up, implementation, conduct, day-to-day activities, interaction with partners and sponsoring agencies, close-out; and planning, development and implementation of new processes and protocols to support research studies and maximize/extend study capabilities.
* Ensures that the conduct of study protocols are in compliance with appropriate rules and regulations and reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
* Oversees and directs the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
* Troubleshoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
* Leads clinical teams in preparing for internal, NU IRB, Sponsor, and FDA audits.
* Oversee & implement resource and allocation and necessary changes in resource utilization required for clinical trials (equipment, etc.)
* Program Development_
* Determines goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations.
* Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
* Provides leadership for planning, scheduling, delivering and maintaining program(s)/project(s) to sustain quality instruction in all educational activity.
* Fiscal Management
* Prepares and monitors annual CTU budget including projections of all sources of revenue and expense; responsible for implementing and monitoring approved operations budget.
* Maintains and monitors all finances supporting the CTU, including the preparation of all study budgets and supporting documentation in grants and contracts.
* Develops and oversees the operational payment structure, monitors payments and patient billing as outlined in project contracts for all funded studies.
* Works with Northwestern Memorial Hospital (NMH) and Northwestern Medical Group (NMG) finance staff to develop strategies for tracking patient research bills and managing invoices for all research projects_._
* Administrative
* Develops and maintains Standard Operating Procedures (SOPs) for the unit’s clinical operations and continuously reviews and monitors clinical conduct and develops new, or modifies existing policy documents, SOPs, and training materials as required.
* Oversees the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.
* Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
* Coordinates and participates in budgetary negotiations with industry sponsors.
* Oversees study sponsors for study tests/procedures.
* Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
* Reviews scientific literature and evaluates and recommends applicable techniques and procedures.
* May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants.
* Oversees RAS activities.
* Liaison with Industry to bring in additional Clinical Trials.
* Oversees Regulatory activities (currently outsourced to NUCATS)
* Provides overall direction and leadership for development of grant applications and renewals relative to CTU operation, in collaboration with RAS.
* Serves as a resource to investigators in preparation of grant applications, including clinical trial accrual reports, financial reports regarding staff effort and CTU services summaries, in collaboration with RAS.
* Responsible for the maintenance of all CTU facilities and equipment to support the mission of the CTU.
* Acts as liaison between institutional investigators and clinical research staff, when necessary.
* Acts as a liaison between the CTU and RAS, NUCATS, NU, NMH, and NMG.
* Responsible for development and maintenance of inter-institutional relationships, pharmaceutical industry representatives, federal grant administrators and auditors.
* Human Resources
* Trains, directs, assigns duties to and supervises research staff, students, residents and/or fellows.
* Provides leadership to the staff.
* Oversees and directs all recruitment activities in collaboration with appropriate PIs, management, and supervisory staff.
* Responsible for implementation of the performance management system including merit review and disciplinary procedures.
* Develops and directs a comprehensive program of staff development including orientation, in-services, continuing education, and staff meetings.
* Ensures that daily operations are appropriate, efficient and effective and are in compliance with improvement opportunities to enable the CTU to achieve its goals and standards.
* Ensures staffing is appropriate to support trial volume.
* Identifies opportunities for alternative staffing, sharing resources, right sizing, and staffing to demand.
* Completes other duties as assigned

What Does A Clinical Research Manager Do At Medtronic

* Manageclinical study personnel focused on conducting clinical programs consistentwith applicable regulations, guidelines, and policies.
* Interprets and executeson policies and procedures appropriate to clinical programs under his/hermanagement.
* Recommends modifications to policies and procedures to largerclinical organization as necessary.
* Accomplishesresults through experienced clinical research employees who exercisesignificant latitude and independence in their assignments.
* Providesongoing training, direction and guidance on all clinical programs under theirsupervision.
* Conductquarterly performance reviews and continuous employee development.
* Provideleadership and program representation with internal partners and externalcustomers.
* Supervisetraining of study personnel including internal staff and external study sites(e.g.
* Principal Investigators, Study Site Support Staff, etc.)
* Functionsas an advisor to the Clinical Department Leadership regarding study strategy,projects, individual tasks and overall study operations.
* Ensuresprojects/programs are completed on schedule and within budget.
* Will drivehighest quality program execution.
* Continually assess best practices andimplement continuous improvement across studies as well as provide input toglobal department program execution.
* Participateon key functional workgroups to drive clinical wide or cross-departmentalinitiatives.
* Providesignificant input and oversight to clinical program budgets.
* Ensuresappropriate resources are maintained to effectively conduct clinical programs.
* Givesdirection to staff on program priorities for various projects assigned to theirarea.
* Proactivelyengages senior clinical management in program risk discussions and provideswell thought out solutions to issues.
* Identifiesopportunities to strengthen clinical program quality and efficiency byassessing resource needs and capacities to ensure business objectives are met

What Does A Clinical Research Manager Do At Stanford University

* Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials.
* Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
* Supervise the implementation of and adherence to study protocols.
* Educate research staff on established policies, processes, and procedures.
* Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
* Develop consent forms for approval by Human Subjects Panel.
* Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
* Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies.
* Submit Investigational New Drug applications to the FDA as required.
* Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
* Monitor Institutional Review Board submissions, and respond to requests and questions.
* Provide leadership and expertise in identifying and completing research grants.
* Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
* Lead or chair committees or task forces to address and resolve significant issues.
* Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
* Analyze trends in recruitment and assure there is a limited number of competing trials.
* Make recommendations for a variety of options within a trial; track physician compliance.
* Assist with analysis of data and preparation of manuscripts and scientific presentations.
* Other duties may also be assigned.
* Qualifications

What Does A Clinical Research Manager Do At Quintilesims

* Responsiblefor direct line management for ISSC team members including resource selectionand hiring performance training and oversight, timesheet review and approvaland team collaboration activities.
* LeadsISSC activities and updates during weekly client teleconferences and internalteam meetings.
* Interactswith sponsors, clinical and contracts teams to prioritize sites to be focusedon for activation.
* Leadsthe development of site qualification questionnaires and protocol review,drawing on medical knowledge and regulatory expertise, to interview sites forpotential involvement in studies or trials.
* Directsthe creation and dissemination of Confidential Disclosure Agreements (CDAs) andFeasibility Questionnaires to sites and follows up accordingly to determineinterest and to meet study timelines.
* Negotiatesthe CDA on behalf of sponsor according to country requirements.
* Overseesthe negotiation of Informed Consent Forms.
* Leadsa team as they assist sites with local IRB/ethics committee submissions
* Leadsthe ISSC team in creation of templates for regulatory documents specific tolocal and central Institutional Review Board (IRB) / ethics committeesubmissions.
* Oversees/leads in the assembly and distribution of regulatorydocuments to sites and/or assembles and distributes regulatory documents as theneed arises.
* NotifiesRegulatory Affairs department and/or assures team members notify RegulatoryAffairs when initial essential documents are available for review.
* Works withRegulatory Department to resolve any concerns.
* Managesquality and regulatory compliance documentation among investigational sites.
* Managesstudy timelines, documents study challenges and communicates them to the, Sr
* Mgr. or Associate Dir. and Project Manager.
* Overseesongoing QC process and periodic investigator site file audits to ensurecompliance with GCP and Novella’s standard operating procedures.
* Communicatesdirectly with the site personnel, or with local CRA in various countries, asappropriate to achieve stated objectives and to ensure files are maintained inan audit ready condition at all times.
* Overseesthe entry of Investigator names inClinical Trial Management System (CTMS)
* Assuresteam members updates CTMS and/or assures that CTMS is updated with documentcollection and all communications made with the site throughout the study.
* Overseecollection and review of regulatory documents for completeness and accuracy
* Responsible for assuring updates are made to CTMS
* Assuresteam members understand budgets for the studies they are working on andmaintain accountable for notifying Project Managers when additional activitiesmay cause the overage on budgets.
* Maintainscontact with Project Managers, Clinical Trial Managers and CRAs to obtainnecessary documentation throughout the trial.
* Assuresthat the appropriate Novella and/or sponsor SOPs are followed.
* Assuresall project documentation is appropriately filed per Novella SOPs.
* Assuresthat any out of scope ISSC activities are alerted to ISSC Management, ProjectManager and team and assures that such activities do not begin until the clientprovides authorization.
* AssistsSr.
* Manager or Associate Dir. in identifying and generating changes in scopewithin the ISSC activities.
* Leadsand reviews the Regulatory Document Management Plans.
* Develops/reviews the Investigator Site File Review Plans.
* Servesas Novella representative in interactions with the sponsor, as appropriate.
* Participatesin proposal preparation and bid defense activities as requested.
* Servesas a team trainer and mentor as new projects are awarded.
* Trainsand mentors new employees in the implementation of the tasks andresponsibilities within their job description.
* Servesas backup to Sr.
* Manager/Assoc Director as requested.
* Performsother duties as required.
* KNOWLEDGE

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How To Become A Clinical Research 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 Research Manager jobs

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Clinical Research Manager Demographics

Gender

  • Female

    77.1%
  • Male

    20.6%
  • Unknown

    2.2%

Ethnicity

  • White

    75.4%
  • Hispanic or Latino

    10.5%
  • Asian

    9.9%
  • Unknown

    3.5%
  • Black or African American

    0.7%
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Languages Spoken

  • Spanish

    40.6%
  • French

    12.5%
  • Chinese

    6.3%
  • German

    6.3%
  • Swedish

    3.1%
  • Portuguese

    3.1%
  • Bosnian

    3.1%
  • Japanese

    3.1%
  • Urdu

    3.1%
  • Dakota

    3.1%
  • Hindi

    3.1%
  • Mandarin

    3.1%
  • Polish

    3.1%
  • Arabic

    3.1%
  • Russian

    3.1%
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Real Clinical Research Manager Salaries

Job Title Company Location Start Date Salary
Clinical Research Manager Matthew Brams, Md and Alice Mao, Md Houston, TX Jul 08, 2015 $157,102
Clinical Research Manager Novartis Vaccines and Diagnostics, Inc. East Hanover, NJ Jan 01, 2013 $139,080
Clinical Research Manager Pulmonary Consultants, PLLC Tacoma, WA Apr 22, 2015 $125,000
Clinical Research Manager Novartis Pharmaceuticals Corporation East Hanover, NJ Jan 01, 2010 $123,136 -
$135,000
Clinical Research Manager Novrtis Pharmaceuticals Corporation East Hanover, NJ Jan 01, 2010 $123,136 -
$135,000
Clinical Research Manager II Millennium Pharmaceuticals, Inc. Cambridge, MA Dec 01, 2009 $122,000
Clinical Research Manager Medtronic, Inc. Santa Rosa, CA Sep 12, 2011 $106,787 -
$128,426
Clinical Research Manager University of Maryland, Baltimore Baltimore, MD Nov 30, 2015 $103,438
Clinical Research & Outcomes Manager Acufocus, Inc. Irvine, CA Oct 01, 2013 $100,786
Cancer Center Clinical Research Grants and Financial Manager University of Virginia Charlottesville, VA Aug 08, 2016 $100,000
Clinical Research Manager Memorial Sloan-Kettering Cancer Center New York, NY Apr 06, 2015 $98,000
Clinical Research Manager Resolution Health, Inc. Columbia, MD Sep 15, 2010 $92,186 -
$94,500
Ctsi Clinical Research Manager Medical College of Wisconsin Milwaukee, WI Mar 02, 2015 $91,350
Ctsi Clinical Research Manager Medical College of Wisconsin Milwaukee, WI Jan 15, 2014 $90,000
Clinical Research Manager Memorial Sloan-Kettering Cancer Center New York, NY Aug 11, 2014 $90,000
Clinical Research Manager Research Pharmaceutical Services, Inc. Fort Washington, PA Oct 01, 2010 $90,000
Clinical Research Manager North Shore-LIJ Health System New York, NY Sep 01, 2015 $89,720
Clinical Research Manager Pulmonary Consultants P.L.L.C Tacoma, WA Sep 06, 2015 $89,000
Clinical Research Manager Ut Southwestern Medical Center Dallas, TX Apr 12, 2011 $81,952
Clinical Research Manager Pulmonary Consultants P.L.L.C Tacoma, WA Sep 05, 2012 $81,000
Clinical Research Manager General Electric Company-Healthcare Wauwatosa, WI Dec 02, 2009 $80,000 -
$90,000
Clinical Research Manager General Electric Company-Healthcare Wauwatosa, WI Aug 22, 2011 $80,000 -
$90,000
Clinical Research Manager South Carolina Nephrology and Hypertension Center, Inc. Orangeburg, SC Nov 14, 2016 $79,622
Clinical Research Manager Dana-Farber Cancer Institute Boston, MA Oct 01, 2015 $74,169
Clinical Research Manager Medex Research Institute, LLC Caro, MI Jan 02, 2016 $70,325
Clinical Research Manager Memorial Sloan-Kettering Cancer Center New York, NY Jun 27, 2014 $70,000

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Top Skills for A Clinical Research Manager

ClinicalResearchCoordinatorsStudyProtocolsRegulatoryDocumentsProceduresClinicalResearchTrialsIRBFDAPrincipalInvestigatorsStudyCoordinatorsCRFCROOncologyDataCollectionClinicalResearchStudiesIIICrasPatientRecruitmentDataManagementResearchProjectsSeriousAdverseEvents

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Top Clinical Research Manager Skills

  1. Clinical Research Coordinators
  2. Study Protocols
  3. Regulatory Documents
You can check out examples of real life uses of top skills on resumes here:
  • Train new and current clinical research coordinators to ensure effective coordination of training activities in the clinical trials process.
  • Developed, wrote and managed investigator initiated study protocols.
  • Facilitate collection of regulatory documents and maintenance of Trial Master File.
  • Developed procedures to ensure participant satisfaction and retention.
  • Provide project management and oversight of pharmaceutical company sponsored clinical research trials conducted in physician office.

Top Clinical Research Manager Employers

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