Reporting to the Director of Clinical Operations, the Senior Manager will be responsible for ensuring excellence in clinical trial planning, execution, and data collection while maintaining compliance with regulatory guidelines. This role will oversee CROs and vendors, ensuring effective study execution from start-up through close-out.

 

Key responsibilities include managing cross-functional study teams, fostering strong partnerships with CROs and vendors, and driving successful trial outcomes. The ideal candidate has a proven track record of executing complex clinical trials on time within the biotech or pharmaceutical industry, delivering high-quality results.

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Responsibilities:

• Manage one or multiple clinical studies, demonstrating expertise in clinical operations and project management.

• Provide cross-functional oversight of internal teams and external partners, ensuring smooth study execution.

• Ensure clinical trials meet scope, budget, timelines, KPIs, and goals.

• Establish and maintain effective communication with internal and external stakeholders to support study objectives.

• Develop and manage project timelines, tools, and metrics, reporting updates to management.

• Identify risks, propose solutions, and implement mitigation strategies.

• Prepare clinical monitoring guidelines and study-related training materials.

• Oversee and manage CRAs, including review of monitoring reports, risk assessment, issue resolution, and trend analysis.

• Monitor clinical study data in EDC and other databases.

• Develop and manage study budgets, including contract approvals, forecasting, and financial oversight in collaboration with finance.

• Oversee eTMF activities, ensuring proper documentation and closeout.

• Ensure timely site activation, enrollment, and data collection milestones.

• Support the completion of essential study documents, including protocols, investigator brochures, consent forms, and study reports.

• Collaborate with Clinical Data Management to ensure timely and efficient database lock, participating in data review and reconciliation.

• Travel may be required (~10%).

• Perform additional duties as assigned.

 

Core Competencies:

• Strong attention to detail and process orientation with exceptional project management, risk assessment, and contingency planning skills.

• Excellent problem-solving, communication, and organizational abilities.

• Adaptability to change priorities, critical thinking, and ability to perform under pressure.

• Collaborative mindset with the ability to build strong cross-functional relationships.

• Proven leadership in strategic planning, organization, and managing multiple projects simultaneously.

 

Qualifications:

• 3–5 years of experience in Clinical Operations.

• Minimum of 1 year of experience in the biotech industry.

• Bachelor's degree or equivalent experience in the biotech or biopharmaceutical field.

• In-depth knowledge of ICH-GCP guidelines.

• Strong ability to prioritize tasks and adapt in a fast-paced setting.

• Proven experience managing clinical trials from early to late phases in hematology and solid tumor oncology.

• Skilled in risk-based decision-making and challenging the status quo.

• Creative problem-solving and flexibility to drive progress.

• Ability to excel in a remote or virtual work environment.

 

If you're excited about this role and eager to work with a team of smart, passionate, and driven professionals, we’d love to hear from you! Send your resume to info@k36tx.com and if you're a great fit, we’ll be in touch. 

 

Join k36 on this exciting journey and make an impact!