Description

FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations

Position Overview

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Client therapeutic areas. Clinical Operations plays a key role in ensuring all Client clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Client’s products.

You will support other Biomarker and Bioanalytical Operations team members in the start-up, maintenance and close-out of clinical studies. You will track and prepare study-specific information, review and participate in the quality assurance of data and/or documents, arrange and assist with meetings and meeting logistics, and assist with development of documents and standard forms.

Example Responsibilities

Tracks and prepares study-specific information using databases, spreadsheets, and other tools.
Reviews and participates in the quality assurance of data or documents.
Arranges meeting logistics, agendas, and assists with minutes.
Interacts with other departments, as needed, to complete assigned tasks.
Assists with development of documents and standard forms.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Work with cross-functional team members across the Oncology, Inflammation and Virology therapeutic areas
May support sample reconciliation for active clinical studies in collaboration with BBOps Study leads on sample tracking with periodic consent verification.
Support sample reconciliation for active clinical studies in collaboration with BBOps Study leads on sample tracking with periodic consent verification.
Experience with eTMF/Veeva system and support eTMF filing
Participate in oral presentations as applicable

Requirements

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

MA /MS /PharmD /PhD with some relevant clinical or related experience in life sciences.
BA / BS / RN with 1 or more years’ relevant work experience.
Some general clinical or business knowledge and experience is preferred.
Working knowledge and experience with Word, PowerPoint and Excel
Excellent verbal, written, interpersonal and presentation skills are required

Knowledge & Other Requirements

Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Aptitude to learn Client’s business and the biopharma industry.
Teamwork and collaboration
Good analytical and organizational skills
Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) is preferred.
Understands how to use basic office programs / tools.
Ability to communicate in a clear and concise manner.
Ability to support a team-oriented, highly matrixed environment.
Ability to execute multiple tasks as assigned.
When needed, ability to travel.

Onsite Offsite

Additional Details

Manager's Requested Bill Rate : (No Value)
Onsite Offsite : Onsite

Cube Hub Inc.

New Jobs

Clinical Project Assistant II*