Clinical Development Scientist
Simon Tyson at CK Clinical is recruiting for a Clinical Development Scientist to join a leading Pharmaceutical company, on a full time, temporary basis for 6 months in the first instance.
As a Clinical Development Scientist you will join the Rare Diseases Global team to drive the delivery of end to end study, scientific and operational excellence from concept to publication/ submission and archiving, acting as a key member of the clinical support model in place.
Key Accountabilities/Responsibilities of a Clinical Study Manager will include:
- Assisting with drafting core protocols, CRF's and analytical plans through discussion with matrix team members.
- Assisting with drafting assigned sections of clinical reports, dossiers, and other documents.
- Reviewing standard format data displays in protocols and CRF's to assure consistency in data capture.
- Assisting in the development of the plan for program drug supply. Participating in the development of overall Lab strategy.
- Contributing to the preparation and maintenance of Investigator Brochures.
- Assisting in producing materials for Investigator meetings.
- Assisting with preparation of expert reports, standard replies, training materials, and organizing internal training meetings.
- Providing overall safety monitoring for the protocol/product during conduct of the study.
- Preparing clinical sections of registration documents such as Investigational New Drug (INDs) & New Drug Applications (NDAs).
- Assisting with the writing of manuscripts and development of abstracts and presentation materials.
As a Clinical Development Scientist, you will have the following qualifications, skills and experience:
- BSc. degree in Life Sciences, Public Health or other related disciplines with extensive clinical development experience.
- A background in clinical development sciences as a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience.
- Strong scientific/analysis skills.
- Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Demonstrated ability to plan, organise 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, good communication and presentation skills and excellent influencing and negotiation skills.
For more information or to apply for this Clinical Development Scientist position please contact Simon Tyson on 01438 743047 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30111 in all correspondence.