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| Reference: |
2805 |
| 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) Manage the overall operational activities involved in the planning, conduct and completion of clinical trials
2) Handle multiple tasks like protocol and CRF development, ordering clinical supplies, collection, review and filing of clinical trial documents, preparation of monitoring guidelines, critical thinking and analysis of study metrics, study variance tracking
3) Solve problem proactively in order to achieve work scope objectives, budgets and timelines within a project
4) Manage clinical research associates who conduct investigator identification, selection, training, and routine monitoring, maintaining and negotiating vendor contracts
5) Manage and execute trials through a combination of internal and external (CRO) staff and other duties as assigned or required
6) Communicate up-to-date information regarding trial progress to the Program Team and management
7) Serve as a primary contact with CRO to ensure appropriate communication
8) Identify potential investigators and clinical sites
9) Serve as primary contact with investigative sites to ensure that quality study deliverables are achieved
10) Manage site and vendor budgets and payments
11) Negotiate contracts with investigational sites and laboratories for content and pricing, ensuring that all regulations and legal requirements are met
12) Prepare and maintain patient recruitment and retention strategies
13) Lead the data review process
14) Maintain clinical study files and oversee the archival process
15) Participate in internal and external meetings
16) Ensure delegation of clinical project work to team members based on skills and abilities
17) Provide input to the performance appraisal process for Clinical Study Team members
18) Prepare and/or oversee IND serial submissions and annual reports
19) Contribute to clinical study reports, etc.
20) Develop and maintain effective working relationships with members of other groups involved in the clinical trial process, particularly Data Management, Regulatory, Safety, Pharmaceutics, and Clinical Monitoring groups within and outside the company
21) Ensure that all clinical aspects of studies are being carried out in accordance with GCP and ICH guidelines
22) Perform other activities (as assigned)
Job Requirements:
1) Bachelor’s degree preferably in Biology or Life Sciences (advanced degree preferred)
2) 3 – 6 years of clinical research or equivalent experience (preferably 2 – 4 of these years as Clinical Study Manager, Clinical Research Associate or a related relevant position)
3) Knowledge of FDA regulatory requirements and Good Clinical Practices
4) Experience in supporting regulatory submissions a plus
5) Ability and desire to work in a team-oriented environment
6) Excellent organizational skills
7) Proficiency in MS Word, Excel, Project and PowerPoint
8) Excellent written and verbal communication skills
9) Willingness and ability to travel (as needed) – up to 25%
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02805.html
Salary: $100k-$130k
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| Healthcare Field: |
Allied Health |
| Category: |
Health Manager |
| 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 |