Clinical Trial Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• The Clinical Operations Lead collaborates with the Clinical Trial Manager and operational team to execute the trial(s).

• This role involves direct coordination with CROs and other auxiliary vendors, as necessary, to oversee pertinent operational tasks for the trial(s).

• The Lead ensures effective communication with the project team through both oral and written correspondence, including status reports to maintain alignment with study timelines.

• Assist in the review, creation, and writing of clinical trial documents and manuals, encompassing but not limited to study manuals, laboratory or biomarker plans, and other supporting materials.

• Develop a Master Informed Consent Form (ICF) template and review/approve changes at the site level.

• Update the template with new risk factors and information regarding amendments.

• Engage in the feasibility assessment and evaluation of investigative sites, working closely with the Clinical Trial Logistics group.

• Coordinate and oversee activities at investigational sites; review monitoring trip reports and provide support to the US monitoring organization.

• Assist in developing and managing study timelines and priorities, including recruitment tools/strategies and patient retention plans.

• Organize and plan meetings with team support.

• Aid in the formulation of the investigational product (IP) and co-medication strategy.

• Take part in data review and resolution of discrepancies.

• Monitor study-specific timelines and key deliverables; emphasize the management of all external vendors.

• Act as a member of the multi-disciplinary trial(s) team.

• Build relationships with investigational sites and institutions to facilitate the trial's conduct.

• Serve as a preliminary liaison for study sites to relay trial information, address inquiries, and adhere to the escalation pathway.

• Take on responsibilities as a member of a working group and tackle special projects, as assigned, to enhance the efficiency, effectiveness, and quality of the Development Operations Department.

⛳️ Requirements

• A BS/BA degree or a relevant qualification with a strong focus on science.

• A minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research backgrounds.

• Candidates must possess experience in managing clinical trials related to non-malignant hematology.

• Must have a solid understanding of ICH Good Clinical Practices and other relevant regulatory/health authority experiences.

• Ability to effectively juggle multiple priorities across various protocols and therapeutic areas simultaneously.

• Prior experience in assisting with the conduct and management of multinational clinical trials is preferred.

• Applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.