Senior Marketing Manager (Saas)

Lead Clinical Research Associate

DEPARTMENT : Ora Europe

LOCATIONS : Remote, Spain

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market.

The Role :

Ora’s Lead Clinical Research Associate (Lead CRA) develops strong clinical site relationships and is accountable for hands-on delivery of project tasks in addition to delegation and oversight of more junior CRA’s project tasks. The Lead CRA will work independently and partner with the CRA line Manager to ensure compliance with study conduct by monitoring site activities regarding ICH / GCP and country regulations, Ora’s policies, and Standard Operating Procedures (SOPs).

What You’ll Do :

1. Independently customize and maintain the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
2. Ensure overall project efficiency and adherence to project timelines; report metrics and out-of-scope activities to the CRA line Manager, Sponsors, or Clinical PM’s.
3. Collaborate with other functional groups within the company such as data management, project management, quality assurance and biostatistics to support milestone achievement and to manage study issues.
4. Manage and follow study activities through ongoing tracking and review of study progress.
5. Conduct review of CRA visit reports within required timeframe, track CRA compliance and escalate quality or non-compliance issues to Monitoring Management.
6. Handle escalations for site management questions and issues for assigned projects.
7. Develop and deliver presentations & training to clients, colleagues and professionals, as required.
8. May be assigned additional responsibilities as needed to support projects.
9. Host routine CRA team calls with a focus on best practice / knowledge sharing.
10. Provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable.
11. Support audit and inspection activities as needed.
12. Adhere to all aspects of Ora’s quality system and compliance requirements.

What We Look For :

1. Bachelor’s degree with 5 years’ experience as a Clinical Research Associate or equivalent combination of education, training and experience.
2. Prior team and/or site lead experience.
3. Ophthalmic experience strongly preferred.
4. Strong attention to detail in order to review CRA visit reports.
5. Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits.
6. Advanced Knowledge of federal regulations governing research and GCPs.
7. Multilingual communication is a plus.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply.