JOB DESCRIPTION
Clinical Operations is responsible for the worldwide execution of all Phase I – IV clinical trials across all clients 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 clients products.
You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross–functional team members.
You will manage certain components of clinical studies and act as a member of the study team.
You will also manage biomarker and bioanalytical vendors.
You will assist in the review of clinical study protocols and other study documents, contribute to process development and/or participate in special projects.
You may also participate in strategic initiatives.

EXAMPLE RESPONSIBILITIES:
Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and
bioanalytical strategies inclientsand Collaborative (CO) programs
Participate in multiple Phase 1–4 clinical study teams
Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)
Accountable for ensuring biological samples collected are of good analysable quality and are collected in adherence to the highest standards of ethics and informed
consent.

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
PharmD / PhD with 2 years relevant clinical or related experience in life sciences.
MA / MS with 3 years relevant clinical or related experience in life sciences.
BA / BS / RN with 5 years relevant clinical or related experience in life sciences.

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.
Ability to manage any component of full cycle study management, from start–up to close–out.
Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
Fully understands protocol requirements and effectively articulates and interprets these. Thorough 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) governing the conduct of clinical studies.
Familiar with standard medical / scientific terminology.
Experience managing the work of external vendors.
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.