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| Company: |
Sterling Life Sciences |
|
| Job Title: |
Assistant Director |
| Job Category: |
Biotech |
| Job Location: |
NJ New Jersey - USA |
| Job Ref. Number for your records: |
2432 |
| Job Description: |
Our client is a biopharmaceutical company. From treating life-threatening and incapacitating diseases.
Job Responsibilities:
1) Manage the operational activities of staff within Clinical Operations in a productive and proactive manner
2) Ensure all time frames and study targets are met with high quality and that costs are effectively managed
3) Coordinate the overall management, development and direction of assigned clinical projects and studies
4) Ensure all projects and studies are performed as per FDA and ICH good clinical practice (GCP) guidelines, federal regulations and within defined budgeting and time limits
5) Assess and allocate resources for assigned studies and provide resource utilization data on a regular basis
6) Assist in departmental fiscal workload projections
7) Lead and direct departmental planning and coordination of study set-up, execution, training materials and guidelines and other project-related and/or department-related duties
8) Recommend and implement innovative process ideas and solutions to impact clinical trials management
9) Provide high-quality leadership, knowledge and training to the clinical operations staff
10) Secure the successful completion of clinical studies, from the successful enrollment of evaluable patients to the delivery of clean data
11) Achieve optimal project parameters of time, quality and cost
12) Assist the Vice President of Clinical Operations in aligning the departmental goals and needs with study objectives
13) Ensure the effective management of studies meeting timelines and expectations
14) Adhere to company SOPs, GCPs, appropriate regulations and high-quality standards
15) Serve as Study Team Leader for projects as assigned
16) Assess the qualifications and capabilities of potential vendors, including CROs and investigators
17) Provide recommendations to management about appropriate service providers to initiate and expedite the conduct of clinical studies
18) Manage vendors as necessary to achieve company objectives
19) Review and/or prepare clinical monitoring and site management plans, including actions for study start-up, recruitment, monitoring and quality data deliverables
20) Provide support for regulatory activities, such as IND Annual Reports and BLA submission materials related to assigned projects
21) Report on performance metrics related to quality, cycle times, cost and potential process improvements
22) Contribute to and maintains standards within Clinical Operations (templates, SOPs, best practices)
23) Conduct other projects as requested
Job Requirements:
1) Bachelor’s degree (Health Science major preferred); advanced degree preferred
2) Minimum 8 years of clinical research experience in pharmaceutical/biotechnology industry (oncology experience preferred)
3) In-depth knowledge of FDA/ICH regulations/guidelines regarding Good Clinical Practices
4) Proficiency in MS Word and Excel, familiarity with PowerPoint
5) Knowledge of MS Project preferred
6) Supervisory experience
7) Ability to proactively recognize study and/or company needs and implement an effective action plan
8) Ability to oversee all aspects of study management, manage study managers and interact positively with all levels of staff
9) Ability to liaise successfully with all levels of management, vendors, including CROs to which significant operational responsibilities have been delegated, and partner
10) Superb organizational skills
11) Ability to efficiently manage multiple high-priority tasks
12) A decision-maker with strong interpersonal, communication and collaboration skills
13) Ability to effectively formulate strategies, develop sound contingency plans and apply tactics and action plans to achieve desired results
14) Willingness to travel – up to 20% (international and domestic)
Applicants are encouraged to apply directly by going to: Sterling Life Sciences job board
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| Skills Required: |
Superb organizational skills
A decision-maker with strong interpersonal, communication and collaboration skills
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| Language Requirements: |
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| Employment Type: |
Full Time
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| Yearly Salary: |
130 USD
|
| Posting Date: |
Oct 19 2007 |
| Education level required: |
Bachelor
|
| Experience (in years): |
3 to 5 Years |
| Job also available in: |
Any city |
| Company: |
Sterling Life Sciences |
| Contact Name: |
Sterling Life Sciences |
| Preferred Method of Contact: |
No Preference |
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