Clinical Operations Project Manager

Job Title: Clinical operation project manager (Project Manager Scientific I (Assistant)

Location: Upper Gwynedd, PA or WestPoint PA or Rahway, NJ

Duration: 2 Years Contract

Note:

Note: 2 year assignment. Hybrid Role- (3days/week onsite- Days: Tuesday and Wednesday must be present onsite and 3rd day can be of contractor's choice).

Candidate has the choice to work either at. Some travel required within these 3 sites. Please do not submit anyone with advance degree(PHD/MD/Doctorate).

Qualifications:

• Education Requirement: BA/BS/Masters in a scientific or technological field of study.

• Minimum experience requirement: 2-3years of experience with clinical trial set-up and execution.

Software: MS office suite, any document review software experience is good to have.

Preferred Experience and Skills:

• Clinical study operation experience.

• Project Management experience.

• Understanding of basic lab techniques in the life sciences.

Skills and Knowledge:

• Well organized and methodical approach to problem solving.

• Ability to understand conflicting needs of key stakeholders.

• Identify and resolve and/or escalate study-related issues.

• Quick learner with the ability to shift as priorities change.

Responsibilities:

Biomarker Operations department is responsible for working with the clinical organizations at Client to ensure the biomarker assays for each study are conducted in an efficient and compliant manner. Experience in Biomarker Operations provides great opportunities for a candidate to leverage their experience in a variety of operational, project management, and clinical operations roles. The role is responsible for the operational set up and management of the biomarker specimens collected in clinical trials. You will partner with cross-functional teams to ensure timely achievement of clinical project related objectives.

The successful candidate will be responsible for the implementation of the biomarker strategy, in accordance with the requirements of quality, ethical and regulatory standards.

Primary activities include, but are not limited to:

• Ensure biomarker related information is accurately captured in protocol language, specimen logistics and workflows, and central lab and clinical site instruction manuals.

• During the protocol planning and execution phase, serve as the subject matter expert for activities associated with biomarker specimens, including interactions with biorepositories, central labs, and other external companies.

• Accurately track and communicate status, timelines, risks, and issues to project teams

• Maintain effective communication and working relationships with project team members, vendors, and other internal Client teams.

• Hold biomarker related operations planning meeting