Sr. Clinical Trial Manager/Associate Director

This a Full Remote job, the offer is available from: reputed company Associate Director, Clinical Operations reputed company 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 reputed company of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we reputed company to reputed company an reputed company 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 reputed company strong reputed company management and guidance to ensure teams reputed company key milestones on time and with reputed company. 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 reputed company 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 reputed company control by developing, implementing, and training on SOPs, as reputed company 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 reputed company communication on study conduct, specimen tracking, and data review; organize investigator meetings as needed.
• reputed company 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 reputed company goals, coaching, providing reputed company feedback, and ensuring resourcing and prioritization to deliver trial milestones with reputed company.
• reputed company

Where You’ll Work This is a U.S.-based remote role that will require quarterly or as-needed reputed company 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, reputed company 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 reputed company to carry out responsibilities.

At reputed company, we reputed company to reputed company 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 reputed company 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 reputed company 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