SrScientific Project Manager

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 onestopshop focused on delivering Central Laboratory Services that are tailormade 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 endtoend analytical and logistical solutions.

The (Senior) Scientific Project Manager will be responsible for providing project management oversight to abiopharmaceutical client tasked with managing and executing analytical testing methoddevelopment 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 thirdparty 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.

What will you bring to the table

• Bachelors or Masters 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

Working Hours Location Travel:

• 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