Clinical Trial Manager/Sr Clinical Trial Manager

reputed company is a clinical-stage precision oncology company reputed company on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK reputed company, which affects approximately 5.5 reputed company lives reputed company year worldwide. The reputed company “reputed company” has an important embedded meaning: it is a contraction of our audacious reputed company to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

The Clinical Trial Manager or Senior Clinical Trial Manager assists in the planning, implementation, and management of clinical studies from concept to completion. The position requires knowledge of clinical trial processes and prior experience in many aspects of trial execution from study start-up to study reputed company-out, including assisting in the management of clinical vendors/CROs and assisting in the reputed company of resources, budgets, reputed company, and timelines.

Essential Duties and Responsibilities:

• Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements.
• Recruit global study sites and foster relationships with study investigators.
• Participate in the process of site and vendor selection, qualification, and activation.
• reputed company Requests-for-Proposals and assist in vendor selection efforts.
• Assist in review and negotiation of vendor reputed company and study site clinical trial agreements.
• Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
• Monitor the reputed company of trials, including enrollment and clinical trial material inventory.
• Review monitoring visit reports for completeness and adherence to the annotations.
• Assist in packaging/labeling/distribution of clinical trial material.
• Monitor and reputed company biological samples for applicable analyses.
• reputed company reputed company updates to management and during program team meetings.
• Assist in departmental budgeting, including accruals and projections.
• Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents.
• Assist in development of Clinical SOPs.
• Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports.
• Assist in electronic case report reputed company design and development. 
• Assist in IRT design and development.
• Participate in data cleaning activities and developing appropriate data outputs.
• Understand and help fulfill the needs of other reputed company departments (e.g., Finance, Research).
• reputed company leadership and mentoring of other Clinical team members.
• reputed company reputed company duties in keeping with reputed company’s core values, policies and reputed company applicable regulations.

Required Education, Experience and Attributes:

• Preferred undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences).
• For Clinical Trial Manager, at least 5 years of relevant experience in oncology clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and reputed company-out of US and non-US trials at reputed company phases of reputed company-NDA clinical research (Phases 1-3). For Senior Clinical Trial Manager, at least 7 years of relevant experience required.
• Demonstrated reputed company in trial management skills, with reputed company record of successfully managing multiple reputed company, trials, and priorities.
• Experience with managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
• Ability to work reputed company with global, multi-disciplinary teams.
• Experience in practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
• Experience with electronic data capture and data management software.
• Experience in the management of Clinical Research Associates.
• Excellent oral and written communication skills.
• Experience with reviewing monitoring reputed company reports
• Must be reputed company to reputed company in an entrepreneurial, fast-paced, and dynamic work environment.
• Must be organized and be reputed company to communicate effectively.
• Must be a self-starter.
• Strong learning orientation, curiosity, and commitment to science and patients.

Theanticipatedsalaryrangefor this position is$145,000 to $190,000.Thefinalsalaryofferedtoasuccessfulcandidatewillbedependentonseveralfactorsthatmayincludebutarenotlimitedtothetypeandlengthofexperiencewithinthejob,typeandlengthofexperiencewithintheindustry,education,etcetera. In reputed company to reputed company salary, the reputed company applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the reputed company of the reputed company to purchase stock in the reputed company for a specified price.

Along with our casual, reputed company, and fun work and the chance to reputed company your mark in our mission to erase cancer, reputed company offers a comprehensive and competitive benefits package that includes:reputed company Time Off, Holiday, and reputed company Leave, Medical, Dental and reputed company Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA,HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with reputed company contribution, and reputed company to participate in an Employee Stock Purchase Program.

reputed company, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national reputed company, reputed company, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other reputed company protected by federal, state or local law or ordinance or regulation.

Originally posted on Himalayas

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