Source Job

• Provide medical input to global clinical studies and advise teams and business partners, focusing on patients' safety and well-being.
• Collaborate with internal departments in preparing clinical development plans, protocols, investigator brochures, and clinical study reports.
• Review and analyze clinical data to ensure the safety of study participants and ensure data accuracy and trial compliance.

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. They're a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries, committed to delivering high-quality, timely services. PSI fosters an environment where a diverse range of colleagues feel welcomed and valued, enabling them to attract and retain top talent globally and build a community where every team member has the opportunity to thrive.

Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.

This position is posted by Jobgether on behalf of a partner company.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate all necessary activities required to set up and monitor a study.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate activities to set up and monitor a study.
• Train and mentor junior staff members.

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the success rate of therapies for patients. They cultivate their culture and have high CRA retention rates compared to industry averages.

Accountable for the operational management and execution of global clinical trial programs (Phases I-III). Ensure adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. Partner with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications.

• Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.

Precision for Medicine combines novel clinical trial designs, operational and medical authorities, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology. They are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development.

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.

• Assist with daily site activities, acting as the primary point of contact for the site.
• Assist with training and mentoring research staff, upholding professional development goals.
• Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.

Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.

• End-to-end management of the clinical trial agreement (CTA) process for global, multi-site clinical trials.
• Develop the study-specific CTA strategy with the Sponsor and internal stakeholders.
• Negotiate CTAs and the corresponding budget directly with clinical sites.

Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.

• Manages central laboratory and specialty vendors across clinical trials.
• Provides support for sample related matters to clinical study teams.
• Assists with vendor selection and oversight.

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.

• Prepare and follow through on bids for new business.
• Oversee financial and contractual performance of Sponsor projects.
• Maintain a strong relationship with the customer during an ongoing clinical trial.

Jobgether is a platform that connects job seekers with potential employers. The company uses AI-powered matching to ensure applications are reviewed quickly and objectively.

• Lead EMEA medical affairs strategy and activities.
• Foster relationships with key opinion leaders and healthcare professionals.
• Support evidence generation and scientific communication.

Scholar Rock is a biopharmaceutical company focused on discovering, developing, and delivering therapies for serious diseases with unmet needs. The company is known for its work in transforming growth factor beta (TGFβ) superfamily biology and has a pipeline targeting neuromuscular disease, cardiometabolic disorders, and cancer.

• Directly manage a remote team of Care Partners, providing guidance and support.
• Design and improve operational processes to ensure high clinical quality.
• Monitor key performance indicators to measure success across different teams.

Medsien provides scalable remote care management for a quality patient experience. Hundreds of organizations trust Medsien's technology solutions to implement remote care management programs, personalize every interaction, and improve the lives of the people who need it most.

• Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities.
• Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs.
• Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease.

• Lead and execute epidemiological and real-world evidence studies.
• Design and oversee study protocols and statistical analysis plans.
• Manage project timelines, resources, deliverables, and risks.

Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Their mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. They have employees who live across the country and enjoy the flexibility of a hybrid model and working from anywhere.

• Oversight for traveling clinical staff supporting decentralized operations at events and sites.
• Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
• Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).

Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.

• Lead complex clinical trials from initiation through completion.
• Oversee cross-functional teams and manage project scope.
• Contribute to high-impact clinical research projects.

This position is posted by Jobgether on behalf of a partner company.