To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $75 to $85/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

• Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all our therapeutic areas.
• Clinical Operations plays a key role in ensuring all our 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 our 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 in our (GS) and 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 analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
• Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery data against contracted scope of work
• Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility
• Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Vendor
• Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
• Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains on track
• Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors
• Maintains internal Biomarker and Bioanalytical Operations databases and document repositories
• Review of relevant documents including protocols, informed consents, and relevant study documents
• Must be able to understand, interpret and explain protocol requirements to others
• Assists in determining the activities to support a project’s priorities within functional area
• Contributes to development of RFPs and participates in selection of CROs/vendor
• Able to examine functional issues from an organizational perspective
• May contribute or participate in special projects.
• Develops tools and processes that optimize project efficiencies and effectiveness.
• May contribute to development of abstracts, presentations and manuscripts
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
• Must have a general, functional expertise to support Process development and implementation
• Provides knowledge and expertise on country specific regulations
• Participates in and manages project meetings and conference calls with vendors and cross-functional teams.
• Develops tools and processes that optimize project efficiencies and effectiveness.
• Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
• May be required to present at internal or external meetings (i.e., investigator meetings).
• Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.
• Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

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.