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 therapeutic areas.
Clinical Operations plays a key role in ensuring all 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 products.
You will support other Clinical Operations team members in the start-up, maintenance, and close-out of clinical studies.
You may manage certain components of clinical studies and act as a member of the study team.
You may also manage vendors and/or manage investigator-sponsored research.
ou may assist in the review of clinical study protocols and other study documents, contribute to SOP development and/or participate in special projects.
Example Responsiblities:
Leads or manage components of Phase I, II or III studies
Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.
May assist as operational contact for studies
Plans and coordinates all operational activities required with the collection, delivery and analysis of biological samples within a clinical trial
Manages study timelines, including documentation and communications
Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in (GS) and Collaborative (CO) programs
Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.
Participates in the review and approval of main study and optional informed consents, and may review additional study specific informed consents
Contributes to SOP development and/or participates in special projects
Develops tools and processes that optimize project efficiencies and effectiveness.
Proactively identifies potential operational challenges and collaborates with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Requirement
Minimum Education & Experience
MA/ MS / PharmD / PhD with 2 + years’ relevant clinical or related experience in life sciences.
BA / BS / RN with 4 +years’ relevant clinical or related experience in life sciences.
Experience in managing the work of external vendors.
Meets all requirements for Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable proficiency.
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.
Knowledge of full cycle clinical study management, from start-up to close-out, and has shown ability to effectively apply this knowledge to achieve targeted study outcomes.
Significant industry knowledge.
Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
Familiar with standard medical / scientific terminology.
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.
Top 3 Required Skill Sets: sample management experience, strong microsoft skills, excellent communication skills
Top 3 Nice to Have Skill Sets: clinical operations/bioanalytical operations experience, laboratory (bench) experience
CPRA: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com. About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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