Sr./Scientific Project Manager at LabConnect in Gaithersburg, Maryland

Job Description:

Overview

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.

What will you do?

• 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 and 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.

• Bachelor's, or Master's level equivalent degree in Life Sciences or related field, required
• 2 - 3 years' experience in the drug development and/or clinical trial processes for Scientific Project Manager, 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
• Experience working in Oncology is preferred
• PMP certified and formal change management training strongly preferred
• 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

• Standard East Coast Business Hours
• Ability to be onsite in Gaithersburg, Maryland Monday - Friday for the first few weeks of orientation
• Upon completion of orientation, position will be remote with the ability to come into the office as needed for meetings
• Strong preference for candidates to be within a commutable proximity to Gaithersburg, Maryland. Will consider individuals on the East Coast as well
• Some travel required

Read more below and get ready for your next great employment adventure!

Some of the Perks our LabConnectors Love:

• Financial Security (base pay, 401k match and annual bonus eligibility)
• Health Benefits beginning on date of hire
• PTO plan plus 10 Paid Company Holidays and 1 day to Volunteer in your community
• Short and Long-Term Disability, Life and AD&D
• We celebrate our differences, which enrich our Culture

We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.

We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.

It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.

Equal Employment Opportunity Posters:

https://www.dol.gov/agencies/ofccp/posters

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email talent@labconnect.com or call +1(423)722-3155.

For more information, visit www.labconnect.com

Other details

• Job Family USA Jobs
• Pay Type Salary