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Study Monitor

Company: Takeda Pharmaceutical
Location: San Diego
Posted on: November 23, 2021

Job Description:

By clicking the "Apply"-- - button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Study Monitor, in our San Diego, California, office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.As a Study Monitor, working on the Global Preclinical and Translational Sciences Operations team, you will be empowered to coordinate and monitor nonclinical GLP and non-GLP development studies at Contract Research Organizations (CROs).-- - A typical day will include:POSITION OBJECTIVES:Review study-related documents, including protocols and reports, for completeness, accuracy, and consistencyPerform and document CRO site visits to monitor study progress, conduct, and compliance with SOPs and regulatory guidanceCollaborate with scientific and operational team members within multiple departments (Drug Safety, Pharm Sci, DMPK, QA, etc.) across Global TakedaPOSITION ACCOUNTABILITIES:Schedule, track, and monitor study timelines, progress, and milestones such as peer reviews and corresponding reports, from internal and external laboratoriesCoordinate protocol review, dose selection, and End-of-Study meetings with internal and external stakeholdersTravel to CROs to monitor critical study activities and executionMaintain study correspondence and budgetary information, including PO generation and invoice approval, for assigned studiesTrack reporting deliverables and graph real-time dataEnsure timely finalization of study reports to support regulatory submissionsEstablish and maintain working relationships with new and existing CROsEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:BS in a scientific discipline desirable, and/or 5+ years of industry experience working at a pharmaceutical company and/or CROA successful candidate will be a self-starter with the ability to problem-solve under minimal supervision and achieve objectives in a timely mannerGood working knowledge of FDA Good Laboratory Practice (GLP) regulations as set forth in 21 CFR Part 58, as well as OECD and ICH guidelinesExperience with the design and conduct of regulated nonclinical studies, including review of study documents, data, and reportsStrong interpersonal and organizational skillsAbility to communicate effectively both internally and externally while acting as liaison between Takeda and CROsProficiency with Microsoft Office and other common electronic platformsAALAS certification highly desirableTRAVEL REQUIREMENTS:Ability to travel domestically and internationally, 50%Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.This job posting excludes CO applicantsWHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to ShineLearn more at Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.#LI-NS1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - CA - San DiegoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, San Diego , Study Monitor, Other , San Diego, California

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