Manager, Clinical Safety

at Company: Harvard Clinical Research Institute (HCRI) in Job Category: Drug Safety
posted on 7/2/08 12:00am

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Company
Harvard Clinical Research Institute (HCRI)

Contact Name:
Recruiter

Email:
hcrijobs@hcri.harvard.edu

Website:
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Job Reference Code:
MBC

Are you looking for more balance in your life? Do you want to work for a company which values the quality of life for its employees? Then consider working for The Harvard Clinical Research Institute, Inc. (HCRI). HCRI is an applied clinical science center that provides integrative resources to support clinical trials and other clinical research.

Working within the unique world-class patient care and research environment of the Harvard Medical School and affiliated institutions, we uphold the highest academic and ethical principles for patient-based research. HCRI facilitates interaction of existing scientific resources within its academic community and broadens interaction among clinical researchers and sponsors of research around the world. HCRI is continuing to expand its leadership presence and currently has an opening for Clinical Safety Manager.

The Clinical Safety Manager is responsible for all aspects of safety oversight and reporting activities relating to clinical trials.

Essential Functions:
1. Responsible for all departmental staff hiring, training and development
2. Responsible for the maintenance, development and implementation of all departmental SOPs and Guidelines.
3. Organize and oversee the production of all deliverables of the Safety department.
4. Maintain responsibility and quality control for Safety Coding. Additionally, serve as the business owner of dsNavigator.
5. Organize training and orientation for new Safety staff.
6. Prepare and set-up projects, including scheduling of resources and timelines.
7. Ensure team members are following appropriate SOPs/Guidelines and completing tasks as scheduled and in accordance the contracts.
8. Act as principal resources manager for project teams and attend project team meetings, as required.
9. Serve as business owner of the safety database Clintrace(TM).
10. Manage the Safety aspects of the projects to completion. Provide project teams with information and guidance necessary to complete projects. Provide oversight of all triaging, collecting, monitoring, processing, and distributing the Serious Adverse Event Reports to sponsor or regulatory authorities and project team within specified timelines.
11. Interface with technical and clinical staff both in-house and with clients (i.e., from pharmaceutical, biotech and device companies).
12. Provide safety guidance to study sponsors, interacting with industry professionals and clinical trialists.
13. Participate in client meetings/presentations.
14. Serve as point of contact for accounting. Update project forecasted hours.
15. Develop and manage departmental and project budgets.

Requirements:
Education: BS degree in health related or science based disciplines requried; some clinical trial coursework or a Masters Degree preferred.

Yrs. of related experience: 3 -5 years clinical trial safety experience in pharmaceutical based clinical trials required; 2 years of management experience preferred.

Work Schedule: 40 hours/week

Qualifications

1. Individual must be detail oriented, and have strong organization and prioritization skills.
2. Excellent communication skills and ability to work effectively within a team environment.
3. Ability to handle multiple projects and stressful situations.
4. Excellent planning, coordination, and supervisory skills.
5. Must be a leader but still a team player.
6. Ability to interact with members of other departments, including both management and non-technical staff.
7. Familiarity with coding dictionaries (WHO, COSTART, ICD-9, MedDRA).
8. Thorough understanding of the clinical trial and drug development process and the role the CRO plays in that process.
9. Understanding of Accounting systems in regards to budgeting and time management.


Benefits:
HCRI is committed to excellence and competence and affords an environment of professional development and education that enhances the personal growth of its employees.

HCRI enjoy competitive salaries and a full range benefits including subsidized parking or discounted T passes; health, dental and vision insurances;, 3 weeks paid vacation; flex time; personal / sick time; 401K; money purchase plan; short and long term disability insurances; tuition reimbursement; career development opportunities; and more!

Please send resumes to Human Resources hcrijobs@hcri.harvard.edu or fax 617.632.1343
HCRI is an equal opportunity employer that values the strength diversity brings workplace.

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