- Oversee clinical trial activities from study start-up through database lock and final study report for one or more clinical programs, ensuring studies are delivered to agreed timelines, quality, and budget.
- Make significant contributions to the planning and start-up of the trial including budget management.
- Be the point of contact for CROs, and monitor the activities of our clients Third Party vendors.
- Represent the clinical team and build positive, working relationships with KOLs, PIs and other site staff to leverage the smooth running of studies.
- Plan and present at Investigator meetings.
- Lead the operationalisation of the clinical development plans and development and implementation of clinical project plans.
- Participate in the development, review, and implementation SOPs.
- Participate in vendor, site and CRO audits and conduct accompanying site monitoring visits.
- Support in the recruitment, hiring, and line management of Clinical Operations professionals when needed
- Minimum 10 years of clinical trial management experience in a biotechnology, pharmaceutical company or CRO. Biotechnology experience desirable.
- Experience building and managing a high-performing cross-functional team.
- Hands-on experience in study management and running global clinical trials.
- Excellent interpersonal skills, strategic thinking and the ability to develop important relationships with key stakeholders across disciplines.
- Excellent analytical, negotiation and drafting skills, with strong oral and written communication skills.
- Willingness to work hard in a dynamic environment with changing priorities.
- Demonstrated ability to prioritise multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
- Our client desires a self-starter, ready to take ownership of a new, key study in a position which will enable you to develop leadership skills and to be part of the growth of the clinical development team
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Clinical Project Director - London Area, United Kingdom - RRxCo.™
Description
RRxCo is partnered with a clinical-stage Biotechnology Company that develops novel medicines for severe immune disorders. This exciting and innovative firm is expanding its team by creating an opening for a Clinical Project Director. Focused on the field of auto-immune disorders, our client is set to develop several assets over the coming years.
Summary
Reporting to the Portfolio Lead, the Clinical Project Director will take a hands-on role in driving activities for their client's new Phase II study to develop treatments for a Rare Disease.
Working remotely with occasional travel to the London Head Quarters, you will be joining a small team which is expected to grow, and you will be a key contributor to ensuring the successful running of a new, global Phase II multi-regional trial.
Deliverables
Profile of the Individual
This opportunity is fully remote with occasional travel to the London Headquarters. You may sometimes be required to travel internationally to participating study sites.
