Senior Scientific Project Manager
About The Position
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. The (Senior) Scientific Project Manager will be responsible for providing project management oversight to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or validation of such assays as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under Good Laboratory Practices (GLP). He/she will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Sr. Project Manager must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.
Requirements
- Bachelor’s, or Master’s level equivalent degree in Life Sciences or related field, required
- 5 - 6 years’ experience in the drug development and/or clinical trial processes for Senior Scientific Project Manager, required
- Equivalent amount of experience managing projects, including timelines, budgeting and forecasting
- Experience with method development, validation and troubleshooting
- Extensive knowledge and experience in bioanalysis within regulatory environments (GLP/ GCP) to include experience with PK/ADA and/or biomarker analysis
- Highly proficient in MS Office Suite, including MS Project, Word, Excel and PowerPoint, Smartsheet and SharePoint
- Strong planning, attention to detail, communication, and organizational skills
- Excellent verbal and written communication skills
Nice To Haves
- Experience working in Oncology is preferred
- PMP certified and formal change management training strongly preferred
Responsibilities
- 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.
- 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.
- Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs).
- Drive the delivery of data transfer specifications and ensure data accuracy.
- Track and reconcile sample testing, resolving any issues that arise.
- Contribute to cleaning and finalizing data.
Benefits
- Base Pay
- 401k Match
- Possible Annual Bonus Eligibility
- Health Benefits beginning on date of hire
- PTO plan
- 11 Paid Company Holidays
- 1 Day to Volunteer in your community
- Short and Long-Term Disability
- Life Insurance
- AD&D
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
