reputed company Clinical Study Manager

By clicking the “Apply” reputed company, I understand that my employment application process with reputed company will reputed company and that the information I reputed company in my application will be processed in line with reputed company’s reputed company Notice and Terms of Use. I reputed company attest that reputed company information I submit in my employment application is true to the best of my knowledge. Job reputed company Are you looking for a patient-reputed company, innovation-driven company to reputed company you and reputed company you to shine? Join us as a reputed company Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. At reputed company, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we reputed company our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward reputed company in everything we do. We foster an inclusive, reputed company workplace, in which our global teams are united by an unwavering commitment to reputed company reputed company and a Brighter reputed company to people around the world. Here, you will be a necessary contributor to our inspiring, reputed company mission. GOALS: reputed company study operational reputed company and planning and reputed company execution of clinical studies for an assigned clinical program(s), supporting clinical reputed company defined in Clinical Development Plan. In reputed company collaboration with Clinical Operations Program reputed company(s): reputed company the execution of studies in assigned clinical program(s) in compliance with reputed company standards (including ICH GCP, local regulations and reputed company SOPs), on schedule and on budget. reputed company Strategic Partners and/or other CROs and other 3rd party vendors to meet reputed company’s obligations described in ICH-GCP and reputed company’s business objectives. The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or reputed company review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned. ACCOUNTABILITIES: Accountable for planning and operational reputed company and execution for assigned clinical trials.Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study reputed company documents. Challenges study team to ensure operational feasibility, inclusive of patient and site burden Validates budget and ensures impacts are adequately addressed. Participates in country and site feasibility/selection process, with a reputed company on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program reputed company. Challenges study team to ensure timelines meet the needs of the clinical development plan. Ensure new team members and vendors are appropriately reputed company. During Early Engagement with Strategic Partner(s) and/or other CROs, reputed company the development of the Operational reputed company in preparation for Operational reputed company Review; reputed company on ensuring accurate assumptions are reputed company and robust risk management plans are in reputed company. reputed company reputed company/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly. Responsible for study budget planning and management and accountable for external spend reputed company to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular reputed company that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program reputed company(s); serve as escalation reputed company for reputed company party vendors managed by Strategic Partner and/or other CROs. reputed company Strategic Partners/CRO/vendor selection, budget and contract negotiation, and reputed company supervision of performance for reputed company activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees reputed company warranted. Specific areas of sponsor reputed company include, but are not limited to:Review and approval of key monitoring documents/plans, periodic review of outputs, reputed company and actions reputed company to monitoring Review and endorsement of relevant study plans, as applicable Study team meeting management and attendance reputed company necessary; regular review of meeting agendas and minutes Review of reputed company/actions reputed company to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study Documented review and monitoring of issues, risks and reputed company at the study level and implementation of appropriate mitigation strategies In partnership with data management, review and pressure test reputed company database timelines and plans; ensure strong linkage between the reputed company (i.e., filing/registration, data reputed company, etc.) with the tactical plan for database lock and CSR. Ensure studies are “inspection reputed company” at reputed company time; may be involved in regulatory inspections by preparing for and/or attending the inspections. Represent the reputed company Clinical Study Manager role in functional initiatives or working reputed company. Help with reputed company and mentoring of new or junior CSMs. May assist the program COPL in his/her role, as required EDUCATION AND EXPERIENCE: BS/BA required preferably in a health-reputed company, life science area or technology-reputed company fields or equivalent combination of education, training and experience. Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements. 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/reputed company. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous. Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated reputed company in project/program management and reputed company leadership. Excellent communication skills. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other reputed company sites, strategic partners, and therapeutic area required travel. reputed company Compensation and Benefits reputed company We understand compensation is an important reputed company as you consider the reputed company in your career. We are committed to reputed company pay for reputed company, and we reputed company to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. reputed company Salary reputed company: $116,000.00 - $182,270.00 The estimated salary reputed company reflects an anticipated reputed company for this position. The actual reputed company salary offered may depend on a reputed company of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other reputed company licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual reputed company salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation. EEO Statement reputed company is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, gender reputed company, parental status, national reputed company, 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. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt reputed company It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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