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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