Bioanalytical Study Manager
Bioanalytical Study Manager
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$ 63000 - 120000
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Thermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate deliberate and driven by our mission to enable our customers to make the world healthier safer and cleaner. At PPD part of Thermo Fisher Scientific we hire the best develop ourselves and each other and recognize the power of being one team. Its not just talk; our award-winning training programs speak for themselves.
Within our Analytical Services team we have a functional service provider solution which is a unique partnership that allows our customers to demonstrate the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.
Role Overview:
Join our dynamic team and lead the charge in supporting our clients pipeline from a bioanalytical perspective. Youll manage bioanalytical operations for pre-clinical studies and clinical trials ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.
Key Responsibilities:
- Vendor Management: Lead the contracting with third-party lab service providers for assay development and validation. Collaborate with business operations procurement and clinical teams to ensure appropriate SOWs and contracts.
- Study Coordination: Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads clinical trial teams and lab service providers to finalize study documents and meet timelines. Support the development of novel Bioanalytical processes.
- Documentation & Data: Provide input into clinical trial documents (e.g. eCRFs ICFs SOWs). Drive the delivery of data transfer specifications and ensure data accuracy.
- Sample Logistics: Track and reconcile sample testing resolving any issues that arise. Contribute to cleaning and finalizing data.
Qualifications:
Education: BA/BS or higher in medical science or a related field plus 5 years (BA/BS) or 2 years (MS) of clinical trial management experience.
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Experience:
- Familiarity with clinical bioanalysis outsourcing operations.
- Knowledge of GLP GCP guidelines and vendor audits.
- Understanding of clinical trial design and data outputs.
- Experience with sample collection instructions and lab manuals.
- Proficiency in data transfer agreements/specifications and data reconciliation.
Skills:
- Strong organizational and analytical skills.
- Excellent written/verbal communication.
- Ability to work both independently and as part of a team.
- Proficiency with Excel and other interactive programs.
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Compensation and Benefits
The salary range estimated for this position based in Maryland is $63000.00$120000.00.This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: Experience:
Manager
Employment Type
Full-Time
Key Skills
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