Manager/Lead – Clinical Site Management/Monitoring | Oncology | Remote Based – Ukraine | Exciting & Fast Growing Biotech: RETAINED SEARCH
This is an exciting opportunity to join an attractive, financially stable, and fast-growing biotech company focused in oncology. You will be responsible for overall clinical site management and establishing/developing important relationships with key site personnel and serve as a face of the Company to the sites in this region. Given the smaller biotech environment, our client is seeking someone who is comfortable working in a hands-on and autonomous type of role, has a flexible attitude and can positively collaborate cross-functionally across all levels within the organization.
This is a very exciting time within the organization, as they have been growing across a number of departments, and this is a great opportunity to join a young and exciting company at the ground-floor and have the autonomy to truly impact the organization. This company has been attracting experienced and talented industry professionals and offers the “best of both worlds,” (i.e. small team comradery and nimble entrepreneurial environment where smart decisions are made quickly without red tape/bureaucracy, while also having the stability/financial backing of its parent company with deep pockets to fund its Oncology development and expand its Oncology pipeline too).
Location: This is a remote-based position located anywhere in the Ukraine.
Attractive Features about this Company & Opportunity:
- Visible and Impactful Position: This is an important role where you will utilize your monitoring/site management experience and country regulations, and have the ability to truly impact the organization (unlike in Big Pharma).
- “Best of Both Worlds” (Biotech culture combined with stability and resources): The company offers all the attractive features sought with an entrepreneurial development/clinical-stage Biotech (small team comradery, impact, agility, quick decision-making, minimal bureaucracy) without the typical risks associated with a “startup.” Our client offers a flat organization structure with minimal layers of management, “red tape,” internal politics and bureaucracy which fosters more communications and swifter decision making (i.e. emphasis on progress and moving things forward).
- Exciting Time to Join: Now is a perfect time to join this company as they are at an exciting inflection point having recently advanced into Phase 3 with their lead compound to treat metastatic breast cancer.
- Great Culture & Forward Thinking Organization: a collegial, collaborative and forward-thinking culture where people are engaged, smart, enthusiastic, and passionate about making a real difference in the lives of cancer patients and their families.
- Overall clinical site management, including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of the Company’s oncology clinical studies.
- Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies.
- Monitor and oversee site activities, both onsite and remotely.
- Accountable for patient enrolment and overall delivery of high quality patient data in established timelines for all designated sites.
- Complete feasibility and site identification activities for new clinical studies.
- Develop and cultivate strong site relationships and ensure continuity of site relationships.
- Oversee and conduct monitoring activities, including remote monitoring and risk-based monitoring.
- Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance.
- Manage the progress of assigned studies by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, drug accountability, data collection, and data query generation and resolution.
- Prepare regulatory submissions, lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance.
Education & Desired Experience:
- Bachelor’s degree in a scientific, nursing, or life sciences discipline.
- Experience monitoring oncology clinical trials is required. Breast cancer trial experience is a plus.
- 4+ years of direct site monitoring experience working at a pharmaceutical/biotech company or CRO.
- Experience building key productive relationships with study investigators, site staff and personnel, etc.
- Must speak Ukrainian fluently.
- Ability and willingness to travel up to 60% of the time as necessary.
Brian Skurka, Director
email@example.com - P 973-656-0220 x738
Cornerstone Search Group, LLC
6 Campus Drive
Parsippany, NJ 07054
Keywords: Clinical Research Associate, Regional Monitor, Clinical Monitor, CRA, Clinical Study Associate, Clinical Site Manager, Clinical Site Management, Clinical Operations, Trial Management, Clinical Study Management, Clinical Trial Manager, oncology, hematology