Senior Study Manager (438638)

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POST DATE 9/12/2016
END DATE 10/10/2016

Advanced Clinical Cambridge, MA

Cambridge, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Associates Degree


Job Description:

OVERVIEW:Responsible for the on-time delivery of a clinical study (studies); clinical operational planning activities and leading study execution; usually of smaller, less-complex studies.The Senior CSM works closely with the Senior Clinical Operations Program Manager (CPOM) on a program or leads one or more studies and may take on additional responsibilities as dictated by study size and complexity (with oversight by Senior COPM). The Senior CSM participates in or may lead the study execution team (SET), oversees study level outsourcing, and takes preventive/corrective action(s) to address study level issues. Reporting Relationships: This role reports to: Clinical Operations Program Manager Matrix Environment: Interface with CPM, Lead Clinical Oversight Managers (LCOMs), Clinical Oversight Managers (COMs), Therapeutic Area Program Director and Clinical Scientist. Also interfaces with Clinical Vaccine Management (CVM), Core Project Team (Core Project Manager), Regulatory, and Clinical Quality Assurance Direct reports: Clinical Trial Assistants (CTAs)Main Responsibilities and Accountabilities: Responsible to execute and/or support the following activities to ensure study delivery:Clinical project management of a clinical studyCreate and drive study level timelineDevelop overall feasibility concept and enrollment plan with input from COMsDevelop and manage study budgetProvide input on operational aspects of the protocolEnsure regulatory compliance and GCP complianceResponsible for oversight of TMF with periodic auditsResponsible for/contribute to vendor selection and management including issue escalationDevelop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)Collaborate with CS&L team to plan and coordinate IMP and non-IMP suppliesPlan, facilitate and lead SET internal meetings as well as act as the lead for vendor meetingsEnsure monitoring plan is developed and consistently executed in collaboration with COMsContribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMsAssigns and documents study specific roles and responsibilities to internal and external team membersConsult with COMs for strategic selection of countries and sitesFacilitate and coordinate communications with external providerEnsure Clinical Operations team and external partner receive study specific trainingReport key study performance information, including study start-up metrics, enrollment, data collection timeliness/qualityFacilitate study close out activities through completion of Clinical Study ReportAct as the primary point of contact for internal groups outside of CR&D (Regulatory, Commercial Development, and Project Management) for study specific informationMaintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerationsEnsure standard processes, tools and procedures are used consistently for study executionCo-monitor as requiredSupport regulatory submissionsReview country/site ICFSupport audits/inspections and resolution of findingsTrack contract execution and drive resolution of site issues in partnership with Site Management and COMsSupport IMP management Position Qualifications and Experience Requirements:Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.Education: At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).Essential Experience: As a guide, a minimum 6+ years relevant clinical research (or related) experience within the pharmaceutical industry. A solid understanding of the drug development process, and specifically, each step within the clinical trial process. Experience in overseeing global clinical trials (pharmaceutical or research institute). Budget forecasting and management. Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. Ability to work independently with some oversight in the support and/or management of clinical trial execution.Desired Attributes: Postgraduate qualifications. Experience in scientific/medical research. Specialist knowledge (e.g. vaccine and/or influenza).Competencies: Demonstrated ability to lead teams and work in a fast-paced team environment. Experienced in working within a Matrix Environment Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report. Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards. Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data. Extensive and comprehensive knowledge of ICH guidelines/GCP, Maintains current medical/scientific/regulatory knowledge. Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs. Excellent written and oral communication skills. Maintains computer literacy in appropriate software.Working Relationships: Internal contacts include VPs, Senior Directors, Directors, Associate Directors, Managers, SET members and research related departments. Other internal contacts include manufacturing, project management, Clinical Safety, CQA, Business Development, Commercial Development, and Commercial Operations. External contacts include MD investigators, scientists, clinical staff, contract research organizations, and outside consultants.Travel requirements: Domestic and international travel required. Amount dependent upon project needs.

Company Description:

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