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myTomorrows · 3 days ago

Clinical Site Manager, Expanded Access Operations

United States

Full-time

Remote

Mid Level

$88K/yr - $115K/yr

3+ years exp

myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. The Clinical Site Manager for Expanded Access Programs will facilitate access to potentially life-saving treatments for patients worldwide and serve as the main point of contact for healthcare professionals in the US, guiding them through the EAP process.

Clinical TrialsHealth CareMedicalPharmaceutical

Growth Opportunities

Responsibilities

Serving as the first point of contact for physicians and their supportive staff throughout the EAP process and coordinating communication with external stakeholders including physicians, pharmacists, clinical trial coordinators, and sponsors

Facilitating document exchange and processing HCP patient requests for medicinal products

Managing customer management tools, including processing patient data into the Electronic Data Capture (EDC) system(s) as needed and generating client reports where required

Reviewing documents/data collection, identifying discrepancies, and collaborating with sites to fulfill regulatory requirements

Collaborating closely with cross-functional teams within our Expanded Access Operations unit (e.g., Regulatory Affairs, Quality, Program Management, Supply Chain) to ensure smooth operations

Drafting and updating program documentation, leveraging existing departmental templates and/or designing new templates

Supporting Program Managers (PMs) with oversight and maintenance of electronic Master Files and improving program processes

Communicating with clients and maintaining a high level of client satisfaction

Qualification

Biomedical degreeHealthcare professional experienceMicrosoft Excel proficiencyElectronic Data Capture (EDC)Proactive accountabilityVerbal communication skillsWritten communication skillsInterpersonal skillsAttention to detailAdaptabilityTeam collaboration

Required

A (bio)medical degree or background

More than 3 years of relevant work experience in working with Healthcare professionals, and Sites as a plus

Excellent verbal and written communication skills in English

Proficiency in Microsoft Office tools, with a focus on Excel

Are self-motivated, adaptable, and thrive in a fast-paced environment where change is continuous

Embody a patient-centric approach, proactive accountability, and considerate collaboration

Work efficiently but precisely with a keen eye for detail

Act proactively, with the ability to anticipate the next steps

Can work both independently, as this is a remote position in the US East Coast time (EST), and as part of a team, demonstrating excellent interpersonal skills

Are eager to learn about new regulations and processes and put them into practice