Job Description

Job Title:

Clinical Research Project Manager

Reports To:

Sr. Director of Laboratory Operations

Job Location:

Pittsburgh, PA (on-site)

Status:

Exempt

Scope

The Clinical Research Project Manager will be responsible for executing processes associated with ongoing and newly initiated clinical studies concerning molecular profiling of human cancers. This position will work closely with Assay Development, Pathology, and Laboratory Operations, as well as external clients to successfully implement and execute clinical trials on behalf of Interpace Diagnostics.


The Clinical Research Project Manager will directly coordinate communications with KOLs, manage manuscript submissions and be up-to-date on relevant literature in the field. This position will communicate project status and opportunities to internal teams. Involvement in laboratory processes and R&D projects included sample tracking, performing testing processes, data compilation and analysis.

Essential Duties and Responsibilities:

In-depth knowledge and understanding of the clinical study process Ability to critically evaluate clinical study protocol design and assist in protocol development Experience in managing multiple clinical studies including study sites, protocols, and data management Project management experience Understanding of clinical study databases and how to interpret clinical study data Demonstrated interpersonal, written, and oral communication skills, both written and oral, especially with key opinion leaders (KOL's) Self-driven and independent work ethic with support of team leaders Able to lead participant meetings for trial implementation, execution and close out, including routine monitoring and planning. Support protocol development, assay development and manuscript writing with understanding of clinical trial data Working knowledge of clinical research processes and applicable local laws pertaining to clinical research investigations + Experience in protocol submission to IRB as well as coordination of submission with appropriate site staff
+ Experience with monitoring of clinical studies, including the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of data
+ Demonstrated experience with clinical trials software/reporting systems
Ability to identify issues proactively, identify resolutions and drive projects to completion Project sample tracking and R&D laboratory testing

Skills and Abilities:

Exhibits a solid knowledge base of medical terminology and clinical endpoints related to cancer and molecular biology; knowledge of pathology related data Ability to perform basic statistical analyses Strong attention to detail and accuracy with excellent organizational skills. Ability to self-motivate and work independently. Demonstrated ability to multi-task and problem solve. Able to follow instructions and management direction. Strong computer skills with emphasis on effectively working with Microsoft Office products and Laboratory Information Systems (LIMS, or similar information systems database). Wet laboratory experience, preferably in PCR and sequencing platforms

Education and/or Experience:

MS in life sciences, bioengineering, public health, or biostatistics; OR + BSN with extensive experience in clinical research coordination and wet lab experience; OR
+ BS degree in life sciences, biology or scientific practice with equivalent combination of education and work experience, including 5+ years of experience managing clinical research studies/data
3+ years managing clinical research trials from implementation to close out preferred + Experience in a molecular lab, oncology or general laboratory preferred
+ Experience and ability to perform statistical analyses preferred