Manager, Clinical Trials

Manager, Clinical Trials

Under the supervision of the Director or designee of Clinical Operations, responsible for overseeing the implementation of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations. Provide clinical and technical expertise for Clinical Programs and Marketing Investigations, including on-site support.

Key Activities :

• Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to : clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training.
• Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.
• Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements.
• Collaborates on clinical data processing in accordance with departmental SOPs and guidelines.
• Verifies, reviews, and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensures that data changes are correctly implemented and captured in the database or data system.
• Assists in the evaluation and analysis of clinical trial data to facilitate the completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions.
• Assists in tracking study-specific payments.
• Provides operational or workflow support to ensure that departmental and cross-functional systems and procedures are efficiently and correctly completed.
• Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality / Compliance.
• Liaising between internal and external stakeholders to facilitate cooperation of others.
• Conducts presentations of clinical information concerning specific projects.

Requirements :

We offer competitive salary & excellent benefits including :

This position may be available in the following location(s) : US - Remote

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $100,000.00 and $150,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

U.S. based employees may be eligible for short-term and / or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

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