Biomarker Operations Project Manager (East Coast)
United States of America, Remote Job ID R0000030193 Category Project Leadership Date Posted 01/02/2025Overview
As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.
In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Collaborative
- Leadership
- Proactive
- Problem-solver
About This Role
Exceptional Opportunity: Biomarker Operations Project Manager at Parexel!
Are you ready to take your biomarker operations expertise to the next level? If so, we are seeking a talented and ambitious Biomarker Operations Project Manager to join our world-class team and work closely with a large global client in advancing their cutting-edge clinical research through innovative biomarker strategies.
As a Biomarker Operations Project Manager, you will support the operational set-up and management of biomarker specimens collected in global clinical trials. As a key contributor to the clinical biomarker strategy, you will be accountable for working effectively with cross-functional teams on planning, implementation, and execution of clinical biomarker specimen collection, testing and data delivery activities.
Description of Role & Responsibilities:
Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using strategies to ensure efficient trial execution
Act as the operational partner to the biomarker scientific leads to aid in implementing strategies that drive clinical trial biomarker programs forward
Participate as a co-author for drafting relevant biomarker sections of clinical study protocols
Work closely with scientists to manage specimen collection, handling, shipping, and storage guidelines that align with biomarker plans and clinical study protocols
Accountable for providing biomarker vendor assay statements of work and data transfer specifications to the clinical teams
Work with data management to effectively transfer biomarker data to clinical data repository from external biomarker vendors
Work with clinical teams and/or central labs to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third party vendors
Maintain and grow effective partnerships with external biomarker vendors and internal client teams
Coordinate sample and assay logistics and serve as a key point of contact with vendors/collaborators for timeline tracking, issue resolution and risk mitigation
Skills and Experience:
Basic knowledge of clinical trial set-up and execution is required
Scientific, medical and/or safety writing and reporting is required (experience in at least one of these areas)
Drug discovery and/or development experience is preferred
Understanding of basic lab techniques in the life sciences is preferred
Ability to understand conflicting needs of key stakeholders
Strong issue identification and resolution skills
Well-organized and methodical approach to problem solving
Ability to collaborate effectively with a cross-functional team
Experience in working with third party vendors preferred
Knowledge of GCP, ICH guidelines, and regulatory requirements
Ability to collaborate effectively with a team
Must be self-motivated, and independent with self-awareness to know when to ask questions
Ability to manage complex projects under accelerated timelines
Can independently prioritize work based on project needs and requirements
Able to learn quickly and be proficient in applicable tools and databases used to support the activities required for this role
Experience with MS Office Suite
Excellent communication skills, both written and oral
Educational Requirements: BA/BS with a science background required
This is a remote position. Candidates located in the EST are preferred, however, consideration will be given to exceptional candidates in the CST who have the ability to work East Coast hours
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Potential Career Path
Parexel offers a growth path with diverse therapeutic areas and clients, so you can grow according to your interests.
- Associate Project Leader
- Project Leader
- Senior Project Leader
- Associate Project Director
- Project Director
- Director, Project Leadership
- Senior Director, Project Leadership
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