Clinical Development Scientist Job

CLINICAL DEVELOPMENT SCIENTIST needed for a contract opportunity with Yoh's client located in Research Triangle Park, NC.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Clinical development sciences
- Study management

WHAT YOU'LL BE DOING:

- Accountable for study execution, tracking and management of study delivery.
- Manages feasibility and determines global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives.
- Develops and maintains the global study budget, ensuring cost effectiveness and addressing and escalating issues as appropriate.
- Ensures set up and maintenance of all systems in order to plan and implement the study and track progress.
- Ensures appropriate clinical trial supply strategy is implemented and managed.
- Develops recruitment plan, manages risk, monitors progress and implements contingencies as required.
- Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
- Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
- Accountable for timely delivery of scientifically and operationally robust study documents.
- In partnership with the EST develops a focused study protocol that meets scientific objectives and can be implemented in the clinical and regulatory environment of all participating regions to provide quality data and ensure timely study delivery.
- Ensures development, review, finalization and delivery of high quality key clinical study documents in order to meet study timelines.
- Ensures accurate maintenance and archiving of study records.
- Accountable for clinical vendor selection and contractual agreements.
- Drives assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services, ensuring compliance with client standards.
- Ensures global feasibility of contractual agreements.
- Accountable for site and monitor training in operational aspects of the study.
- Ensures monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented.
- Ensures continuous direct contact with in-country personnel to provide ongoing operational support.
- Accountable for study related communications and for resolution or escalation of operational issues.
- Develops study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders.
- Ensures processes are in place to address or escalate study issues as they arise.
- Ensures a Lessons Learned meeting takes place, captures and shares best practices.

WHAT YOU NEED TO BRING TO THE TABLE:

- BSc. degree in Life Sciences, Public Health or other related discipline with extensive clinical development experience.
- A background in clinical development sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience.
- Track record of study/program management
- Strong scientific/therapeutic expertise in Immune mediated diseases preferred.
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional Matrix teams.
- Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics.
- Demonstrated expertise in the identification, evaluation and selection of key global preferred provider partnerships.
- Strong leadership skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.