STEMdiversity on Demand/Cambridge, MA
Major Pharmaceutical Company headquartered in Cambridge, MA is looking for a Bioanalytical Study Manager
Local candidates or in the NorthEast area
Bioanalytical Study Manager, Associate Scientist III
Research & Preclinical Development
Job Description The Bioanalytical Study Manager (BSM) will support study management and operational aspects of bioanalytical outsourcing by coordinating PCDS study activities and effectively meeting study and program specific timelines and milestones.
The person in this role will assume primary responsibility as liason between the PCDS bioanalytical development scientists, PCDS study managers (Tox/PK), Global Clinical Operations and various contract sites as relevant and appropriate. This person will be responsible for coordinating the timing and execution of sample testing as well as monitoring study activities at contract sites. The BSM will provide input into clinical study documents such as the scope of work and timelines, as well as oversee the generation and finalization of Bioanalytical reports. Bionanalytical Study Manager needs to possess a good understanding of study activities, problem solving skills, good planning, organizational and communication skills.
Job Responsibilites Include:
1. Participate in Study Management Team meetings and contribute to time line and goal setting
2. Facilitate information flow and data flow between study teams, departments and vendors
3. Provide input to operational study documents
4. Initiate quotes/work orders for all bioanalytical work
5. Ensure completion of facility audits
6. Schedule work with outsourcing vendors and chair operational meetings with all contract labs
7. Aid in coordination of sample shipment from CROs to contract labs for time critical analyses
8. Aid in sample reconciliation of samples and data
9. Monitor assay performance
10. Review and release data generated at contract labs as needed
11. Prepare budgets and update latest estimate for outsourcing costs
12. Track assay/study activities including planned and completed milestones
13. Communicate with development and PK scientists regarding assays and data
14. Communicate study time lines and activities to all relevant personnel and vendors
15. Some travel possibly required (i.e. other company sites, Vendor facilities, Seminars, etc
Qualifications
1. Relevant experience in clinical
study management (data and samples)
within a GxP (preferably GLP)
regulated environment.
2. Strong experience within a
clinical study management workflow.
3. Strong working knowledge of MS
Office.
4. Demonstrated computer,
documentation/writing and
organizational skills, as well as
excellent communication skills.
5. Ability to work independently
and in a team environment.
6. Excellent time management and
organizational skills and multi-
tasking ability.
7. Strong attention to details.
8. Strong communication skills
9. Ability to travel as needed
Education
Bachelor's in a scientific discipline
with minimum of 5 years of relevant
industry experience. Clinical study
team and/or project management
experience a necessary requirement
for consideration.
Apply To Job![]()
Major Pharmaceutical Company headquartered in Cambridge, MA is looking for a Bioanalytical Study Manager
Local candidates or in the NorthEast area
Bioanalytical Study Manager, Associate Scientist III
Research & Preclinical Development
Job Description The Bioanalytical Study Manager (BSM) will support study management and operational aspects of bioanalytical outsourcing by coordinating PCDS study activities and effectively meeting study and program specific timelines and milestones.
The person in this role will assume primary responsibility as liason between the PCDS bioanalytical development scientists, PCDS study managers (Tox/PK), Global Clinical Operations and various contract sites as relevant and appropriate. This person will be responsible for coordinating the timing and execution of sample testing as well as monitoring study activities at contract sites. The BSM will provide input into clinical study documents such as the scope of work and timelines, as well as oversee the generation and finalization of Bioanalytical reports. Bionanalytical Study Manager needs to possess a good understanding of study activities, problem solving skills, good planning, organizational and communication skills.
Job Responsibilites Include:
1. Participate in Study Management Team meetings and contribute to time line and goal setting
2. Facilitate information flow and data flow between study teams, departments and vendors
3. Provide input to operational study documents
4. Initiate quotes/work orders for all bioanalytical work
5. Ensure completion of facility audits
6. Schedule work with outsourcing vendors and chair operational meetings with all contract labs
7. Aid in coordination of sample shipment from CROs to contract labs for time critical analyses
8. Aid in sample reconciliation of samples and data
9. Monitor assay performance
10. Review and release data generated at contract labs as needed
11. Prepare budgets and update latest estimate for outsourcing costs
12. Track assay/study activities including planned and completed milestones
13. Communicate with development and PK scientists regarding assays and data
14. Communicate study time lines and activities to all relevant personnel and vendors
15. Some travel possibly required (i.e. other company sites, Vendor facilities, Seminars, etc
Qualifications
1. Relevant experience in clinical
study management (data and samples)
within a GxP (preferably GLP)
regulated environment.
2. Strong experience within a
clinical study management workflow.
3. Strong working knowledge of MS
Office.
4. Demonstrated computer,
documentation/writing and
organizational skills, as well as
excellent communication skills.
5. Ability to work independently
and in a team environment.
6. Excellent time management and
organizational skills and multi-
tasking ability.
7. Strong attention to details.
8. Strong communication skills
9. Ability to travel as needed
Education
Bachelor's in a scientific discipline
with minimum of 5 years of relevant
industry experience. Clinical study
team and/or project management
experience a necessary requirement
for consideration.
Apply To Job
Source: Venture Beat