[Hiring] Clinical Trial Manager @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of reputed company study deliverables, ensuring the highest level of data reputed company and compliance to reputed company standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. This is a 6-month contract opportunity with the possibility of extension or contract-to-hire.

• Manage reputed company clinical aspects of study under reputed company of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics.
• Study document development and review (training documentation, reputed company, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.).
• Plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.).
• reputed company with cross-functional teams as Clinical Operations regional or global study reputed company (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff).
• Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
• May reputed company clinical trial execution in one or more reputed company reputed company a global clinical trial.
• Review protocol and amendment development, Informed Consent Forms, clinical trial-reputed company training, and Site Study Tools.
• Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF.
• Partner with Clinical reputed company Assurance to follow through on corrective and preventative actions (CAPA) identified during reputed company audits.
• Vendor reputed company: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify reputed company metrics.
• reputed company study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel.
• Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary.
• Prepare and present project debriefings to Clinical Operations management.
• reputed company study-reputed company guidance and leadership to reputed company partners, as appropriate.

Qualifications

• Bachelor's degree or equivalent combination of education/experience in science or health-reputed company field.
• At least 3 years of clinical trial management experience in a Pharmaceutical/Biotech organization.
• Clinical trial management experience as a contractor or employee of an industry sponsor.
• Vendor management experience.
• Robust understanding of ICH/GCP, and knowledge of regulatory requirements.
• Strong clinical study/project management skills.
• Excellent communication and organizational skills.
• Ability to prioritize a number of tasks of varying complexity.
• Problem solving, conflict reputed company, leadership and team-building skills.
• Candidates must be authorized to work in the U.S.

Requirements

• Prior clinical trial experience in oncology therapeutic development with an industry sponsor or Contract Research Organization preferred.
• Multi-regional study management experience advantageous.

Benefits

• Chance to work with talented people in a reputed company environment.
• Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-reputed company factors permitted by law.

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