Clinical Site Manager, Expanded Access Operations

myTomorrows•New York, NY

1d•Remote

About The Position

As a Clinical Site Manager for Expanded Access Programs (EAPs), you will play a pivotal role in facilitating access to potentially life-saving treatments for patients worldwide. By joining our Site Management team, you will become the main point of contact for healthcare professionals (HCPs) in the US/US East Coast time zones, seeking access to treatment under expanded access for their patients. You will guide HCPs through the entire EAP process, offering support at all steps, including medical review and approval, fulfilling all regulatory requirements, ordering, shipment, and data collection. As the primary liaison for HCPs, you will be responsible for the communication with clinical sites and coordination with key stakeholders, including physicians, pharmacists, clinical trial coordinators, sponsors, and our internal teams. You will ensure patients get treatment as soon as possible and the HCPs get fully supported.

Requirements

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. Speaking one or more additional languages is a plus
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.

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.

Benefits

Impactful work that helps patients gain access to potentially lifesaving treatments.
International work environment, scale-up energy, and a flat organizational structure that encourages creativity and accountability.
Competitive salary, annual performance bonus, and an Employee Stock Option Plan.
Health insurance benefits through Cigna.
401K where we match 100% of employee contributions up to the first 3% of pay and 50% of employee contributions to the next 2% of pay.
Great career development opportunities in a fast-growing company.
Learning and development budget alongside internal knowledge-sharing sessions.
Remote working model. We also have an office in Brooklyn in where you can work with colleagues.
Policies to support working parents.
Unlimited access to professional guidance by certified psychologists via OpenUp
An annual ‘myTomorrowland’ which is a 2-day company-wide celebration!