The Company
My client is a small CRO who specialise in Ophthalmology and are seeking an Associate Director, Clinical Studies/Project Director to join their dynamic team.
The Role
Responsible for oversight of clinical team for one or more projects
Serves as an escalation point with the sponsor and vendors across all functional areas of the project
Responsible for client satisfaction and overall study delivery per contracted scope and timelines
Skills & Attributes - Must Haves:
·Highly customer service oriented and have creative initiative with a positive attitude, diplomatic to a fault
·Confident communications and leadership style.
·Understands and shares the value of developing and maintaining good relationships internally and externally.
·Able to work in a fast-paced environment and easily adapt to changing priorities.
·Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented.
Responsibilities:
Project/Program Management
Oversees the scope of work, objectives, quality of deliverables, and other project and study management activities.
- Works actively with the study team to review study data and ensure data quality. Monitors the qualitative and quantitative progress of study and research implementation activities; oversee study-specific reporting and tracking of key indicators for evaluation of site performance and study progress.
- Serves as management contact with Sponsor with regular communication and check-in.
- Develops and executes strategies to ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals, and follow all applicable regulations and company policies and procedures.
- Provides reports to leadership of project health and issues.
- Participates in proposal and budget development, evaluate feasibility of potential programs and impact on company operations and goals, negotiate and recommend decisions on behalf of the organization.
Therapeutic Expertise
- Provides therapeutic area expertise to study team members, sponsor, and vendors, in protocol development, document development (e.g., clinical management and monitoring plans) and in general study conduct.
- Participates in business development activities, as needed.
Management/Guidance
- Provides support, coaching, and oversight to Clinical Study Managers and other team members
- Serves as the escalation point of contact for the client and vendors.
- Serves as the team lead for projects and provides line management to staff team members.
Requirements:
- This position requires a B.S./B.A. or advanced degree in a health-related or scientific field and at least ten years of experience in clinical research (or equivalent in education and experience)
- Must have a solid understanding of clinical research operations including GCP and regulatory requirements and operational procedures.
- Experience in ophthalmology preferred. Experience in a CRO setting is strongly preferred.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything