[Hiring] Clinical Trial Manager @reputed company

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a well-funded, reputed company listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At reputed company, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. reputed company, Inc. is a biotechnology company seeking to reputed company differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the reputed company standard of care for inflammatory and immune diseases because we reputed company people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, reputed company reading! Role Summary We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and reputed company regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to reputed company and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries.

Key Responsibilities

• reputed company study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and reputed company budget for assigned regions
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study reputed company risks
• reputed company and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents
• Review and manage study reputed company plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan
• Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions
• Review CRO and vendor reputed company/work orders and specifications to align with study objectives
• Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, reputed company)
• Participate in data cleaning and manage database lock activities with cross functional team
• reputed company review and approve essential document packages to reputed company timely site activations
• Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Participate in TMF review and ensure quality and completeness throughout end of the study
• Ensure the study is always “inspection ready”
• reputed company and coach the functional activities of Clinical Trial Associates allocated to the project Ideal Candidate
• Bachelor’s degree in life science or equivalent
• Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization. Biotech experience strongly preferred.
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each reputed company reputed company the clinical trial process
• Proven proficiency in overseeing reputed company studies being managed in house and by a CRO
• Demonstrated ability to reputed company teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
• Experience selecting and managing clinical vendors to support study activities
• Enjoys building relationships with KOLs and site personnel
• Demonstrated ability to build and deliver on patient enrolment strategies
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to review and comprehend reputed company scientific concepts and clinical data
• Strong planning, time management, and coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and reputed company clinical programs
• Excellent written and oral communication skills
• Position requires up to 35%travel, including mandatory in-person attendance at reputed company reputed company Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the reputed company San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $145,000- $160,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. reputed company Offer
• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, reputed company participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here 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. Apply tot his job

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