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| Reference: |
2806 |
| Date Posted: |
4/21/2008 |
| Organization: |
Sterling-Hoffman Life Sciences |
| Employment Type: |
Full Time |
| Location: |
Massachusetts, MA |
Description:
Our client is a rapidly growing pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various pains therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees.
Job Responsibilities:
1) Recruit staff members of the Clinical Operations Department
2) Develop and manage current staff
3) Ensure career growth and career development opportunities for the staff
4) Prepare and manage monthly, quarterly and annual departmental budget
5) Manage clinical trial budgets and timelines in conjunction with finance business partners
6) Plan resources within Clinical Operations to implement and complete clinical studies on-time, within budget and with high quality
7) Develop and implement departmental of SOPs and WPDs
8) Ensure appropriate planning for all newly planned studies
9) Manage expectations for newly developed studies in relation to other commitments
10) Ensure that all internal and external reviewers have been included in process appropriately
11) Provide oversight for strategic decisions in the department (e.g. CROs and other vendor strategies)
12) Ensure quality delivery of each clinical study goals within agreed budgets and timelines
13) Convey, organize and summarize (as appropriate) results of clinical studies for use in modules of the NDA assembled by the CRO
14) Ensure high quality and timely execution of the clinical studies from protocol development though clinical study report
15) Work effectively with other groups and department members in team situations (e.g. regulatory, non-clinical, CMC, biostatistics, etc.)
16) Ensure that high-quality operational performance aligns with therapeutic area strategies and goals
17) Interact with the senior management about clinical study conduct and activities
18) Ensure integration and coordination of clinical study management, monitoring, data management and data analysis functions for the timely completion of high-quality publications (i.e. posters, abstracts and study reports)
19) Understand when Clinical Operations issues effect other departments and communicate effectively and proactively with those departments
20) Read situations and use the best and most fitting communication style and behavior to achieve desired outcomes while maintaining positive working relationships
21) Meet attendees (proactively) to identify whether meetings are needed and if so to identify agenda items
22) Prepare agendas
23) Lead meetings effectively, including understanding interpersonal dynamics and encouraging discussion while maintaining control of meeting
24) Prepare and/or review meeting minutes and follow-up with attendees (as needed) to ensure that action items are addressed
Job Requirements:
1) Bachelor's in Biological Sciences or Pharmacology, or in clinical trials/studies preferred
2) 8+ years of relevant clinical experience in the pharmaceutical industry or equivalent
3) Demonstrated ability to successfully develop, implement, manage and complete clinical trials
4) Experience in managing staff as well as mentoring and development of junior staff
5) Thorough understanding of FDA regulatory requirements and good clinical practices
6) Resource management experience
7) Ability and desire to work in a team-oriented environment
8) Demonstrated ability to lead
9) Proficiency in MS Word and Excel
10) Excellent interpersonal skills
11) Excellent verbal and written communication skills
12) Ability to travel as needed
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02806.html
Salary Range:$130k
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| Healthcare Field: |
Biotechnology |
| Category: |
Clinical Research Associate |
| SubCategory: |
None |
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Job Posted By:
Similee Harvey
Sterling-Hoffman Life Sciences
800 West El Camino Real ,Suite 180
Mountain View
United States
94040
View more jobs posted by Similee Harvey |