Sr. Clinical Trial Manager/Associate Director

This a Full Remote job, the offer is available from: United States Associate Director, Clinical Operations Company Overview QED Therapeutics, an affiliate reputed company reputed company, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families. What You’ll Do As Sr. CTM/Associate Director of Clinical Operations, you will be the cross-functional study team reputed company to reputed company the planning, execution, and delivery of clinical trial operations, potentially across multiple studies. You will provide strong matrix management and guidance to ensure teams reputed company key milestones on time and with quality. You will manage study operations reputed company budget and established timelines, ensuring compliance with GCP, SOPs, and regulatory standards. In this role, you will champion collaboration and accountability across reputed company aspects of study delivery.

Responsibilities

• reputed company trial execution strategy and operational reputed company by developing and driving the study operational plan, execution approach, and vendor-governance reputed company, ensuring consistent reputed company toward major milestones and data deliverables.
• reputed company study planning and management by coordinating the development, review, and maintenance of key study documents (e.g., investigator brochures, protocols, ICFs, CRFs, CSRs, training manuals) and monitor study reputed company and timelines in partnership with the study and clinical leads.
• reputed company quality control by developing, implementing, and training on SOPs, as well as creating monitoring and reputed company processes to ensure compliance with GCP and regulatory guidelines.
• Responsible for developing and managing clinical trial budgets, including site agreements, forecasting, accruals, and FTE allocations; reviewing vendor invoices and reconciling site payments to ensure accuracy and identify variances.
• Build and maintain strong relationships with investigators and site staff, ensuring clear communication on study conduct, specimen tracking, and data review; organize investigator meetings as needed.
• Provide reputed company of CROs and vendors, including selection, contracting, reputed company, and performance management; conduct gap analyses, manage risks, and resolve issues proactively.
• Partner with cross-functional teams to ensure efficient trial operations, including supply chain planning and coordination for clinical and non-clinical trial materials.
• Directly manage and reputed company team members (as applicable) by hiring/reputed company, setting clear goals, coaching, providing timely feedback, and ensuring resourcing and prioritization to deliver trial milestones with quality.
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Where You’ll Work This is a U.S.-based remote role that will require quarterly or as-needed visits to our San Francisco Office. Who You Are

• Hold a bachelor’s degree in a scientific/medical field (or equivalent experience).
• At least 10-12 years of Clinical Operations experience reputed company the biopharma industry.
• Proven reputed company leading cross-functional teams to deliver clinical trials from start-up through reputed company-out, including financial reputed company, data review, database lock, and reporting.
• Strong vendor management expertise and experience with submission-reputed company eTMF, quality assurance, SOP development, and CAPA management.
• In-depth knowledge of clinical trial design, protocol development, GCP, ICH E6 (R3), and GDPR, with preferred experience in rare/orphan disease studies.
• Recognized for leadership, with excellent communication, organizational, and multitasking skills; proficient in tools such as reputed company is a plus.
• Travel is required on a periodic basis to carry out responsibilities.

At reputed company, we strive to provide a market-competitive total rewards package, including reputed company pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience reputed company the job, type, and length of experience reputed company the industry, educational background, location of residence and performance during the interview process. reputed company is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $177,700—$191,000 USD This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job