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| Job #02421 |
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| About our client |
| Our client is a Fortune 500 company and a global leader in its sphere. The company has a strong pipeline of products, which includes pharmaceuticals and healthcare (both consumer and animal). |
| Position |
Location |
| Senior Clinical Scientist |
Massachusetts |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Coordinate and lead Safety Review Team’s quarterly review meetings of small/complex projects 2) Oversee the development of Informed Consent prototypes and review of site-specific ICFs 3) Coordinate and author clinical sections of annual reports, INDs 4) Assist in strategic program planning 5) Demonstrate understanding of scientific concepts, therapeutic area knowledge, proficiency in medical terminology, and excellent command of GCPs, departmental SOPs, etc. 6) Interface and communicate with project team effectively and chair committees 7) Facilitate large/complex projects with great attention to detail 8) Handle small/complex projects with great attention to detail 9) Perform literature reviews and present and discuss results 10) Demonstrate excellent verbal and written communication skills, as well as strong presentation skills at project reviews and governance meetings 11) Assist in the development and management of project and study budgets 12) Handle investigator and medical communications 13) Participate in the development of protocol-specific site monitoring and training Develop the scientific portions of the 14) Study Reference Manual 15) Respond to site’s scientific questions and escalates to MM and CTA as appropriate 16) Oversee meeting representation and attendance 17) Participate in Study Team, meeting and presentations, as well as other CR&D-related meetings with minimal supervision 18) Serve as protocol lead as well as a member of a broad range of CR&D-related and ad hoc committees as needed 19) Perform study site initiations develop proficiency with standard business software, e.g., MS Office 20) Develop the scientific portions of the Study Reference Manual |
| Requirements |
1) BS/BA degree preferably in scientific/healthcare field or master’s degree with minimum 5 years of relevant work experience or equivalent 2) Ph. D degree with at least 2 years of relevant work experience or equivalent 3) Minimum 6-7 years of work experience in a relevant field including at least 6 years of experience with a solid track record as a Clinical Scientist having attained the level of Senior Clinical Scientist for at least 2 years or equivalent 4) Experienced in conducting efficacy and safety endpoint monitoring, including on-site evaluation 5) Clinical experience preferred 6) Thorough experience in efficacy and safety end point monitoring 7) Good command of GCPs, departmental SOPs 8) Excellent understanding of clinical operations, including clinical systems, departmental procedures, and policies 9) Experience in solving a great variety of complex problems and follow through to resolution 10) Ability to drive the process for most assignments and meet timelines 11) Proficiency in medical terminology 12) Proficiency in standard business software, e.g., MS Office |

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