Clinical Operations Manager

3 weeks ago

San Mateo, United States ACL Digital Full time

FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations

6months contract


POSITION OVERVIEW:

Onsite In Foster City- Hybrid


Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all

Gilead 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 Gilead’s 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 Gilead (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/vendors

• 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.

  • Clinical Operations Manager

    3 weeks ago

    San Mateo, United States Integrated Resources, Inc ( IRI ) Full time

    Job Description:Function: Clinical Operations – Biomarker and Bioanalytical OperationsPosition 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...

  • Clinical Operations Manager

    3 weeks ago

    San Mateo, United States Integrated Resources, Inc ( IRI ) Full time

    Job Description:Function: Clinical Operations – Biomarker and Bioanalytical OperationsPosition 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...

  • Clinical Operations Manager

    4 weeks ago

    San Mateo, United States Integrated Resources, Inc ( IRI ) Full time

    Job Description:Function: Clinical Operations – Biomarker and Bioanalytical OperationsPosition 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...

  • Clinical Operations Manager

    4 weeks ago

    San Mateo, United States Integrated Resources, Inc ( IRI ) Full time

    Job Description:Function: Clinical Operations – Biomarker and Bioanalytical OperationsPosition 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...

  • Clinical Operations Manager

    3 weeks ago

    San Mateo, United States ACL Digital Full time

    FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations6months contract POSITION OVERVIEW:Onsite In Foster City- HybridClinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring allGilead clinical trials are performed...

  • Clinical Operations Manager

    4 weeks ago

    San Mateo, United States ACL Digital Full time

    FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations6months contract POSITION OVERVIEW:Onsite In Foster City- HybridClinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring allGilead clinical trials are performed...

  • Clinical Trial Operations Manager

    4 weeks ago

    San Mateo, United States ACL Digital Full time

    Job Title: Clinical Trial Manager Location: Foster City, CA Duration: 06 Months Description: FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations POSITION OVERVIEW: Onsite In Foster City- Hybrid Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical...

  • Clinical Trial Operations Manager

    3 weeks ago

    San Mateo, United States ACL Digital Full time

    Job Title: Clinical Trial ManagerLocation: Foster City, CADuration: 06 MonthsDescription:FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations POSITION OVERVIEW: Onsite In Foster City- Hybrid Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical...

  • Clinical Trial Operations Manager

    4 weeks ago

    San Mateo, United States ACL Digital Full time

    Job Title: Clinical Trial ManagerLocation: Foster City, CADuration: 06 MonthsDescription:FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations POSITION OVERVIEW: Onsite In Foster City- Hybrid Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical...

  • Clinical Trial Operations Manager

    3 weeks ago

    San Mateo, United States ACL Digital Full time

    Job Title: Clinical Trial ManagerLocation: Foster City, CADuration: 06 MonthsDescription:FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations POSITION OVERVIEW: Onsite In Foster City- Hybrid Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical...

  • Clinical Trial Operations Manager

    4 weeks ago

    San Mateo, United States ACL Digital Full time

    Job Title: Clinical Trial ManagerLocation: Foster City, CADuration: 06 MonthsDescription:FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations POSITION OVERVIEW: Onsite In Foster City- Hybrid Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical...

  • Clinical Trial Operations

    7 days ago

    San Mateo, United States ACL Digital Full time

    Job Title: Sr. Clinical Trial Management Associate (Senior CTMA)Location: Foster City, CADuration: 06 MonthsDescription:JOB TITLE: Sr. Clinical Trial Management Associate (Senior CTMA) FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations Top 3 Required Skill Sets: sample management experience, strong microsoft skills, excellent...

  • Director of Clinical Operations

    2 months ago

    San Antonio, United States Worldwide Clinical Trials Full time

    Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...

  • Clinic Manager

    1 week ago

    San Mateo, United States Claire Myers Consulting Full time

    For over 45 years, our client has been leading the fight against poverty in San Mateo County. They're the only organization that delivers the full breadth of essential services and personalized support to the working poor. By ensuring their clients are fed, clothed, healthy, and housed, our client helps them create their own stability and remain an active,...

  • Clinical Manager

    5 days ago

    San Mateo, California, United States Source EQ Full time

    Job DescriptionJob DescriptionJob descriptionCompensation and Bonus Package115-125k NegotiableAmazing benefitsMedical, dental, and vision coverage for you and your family including low cost optionsGenerous PTO planGenerous paid Holidays403(b) Retirement Plan with a Match, plus a potential employer discretionary contribution after year oneAbout the...

  • Clinical Trials Manager

    4 weeks ago

    San Mateo, United States LanceSoft Full time

    Job Description: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 allclinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that...

  • Clinical Trials Manager

    4 weeks ago

    San Mateo, United States ATR International Full time

    We are seeking a Clinical Trials Manager for a very important client Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Company therapeutic areas Clinical Operations plays a key role in ensuring all Client clinical trials are performed in accordance with applicable SOPs, company policies and...

  • Clinical Trials Manager

    3 weeks ago

    San Mateo, United States ATR International Full time

    We are seeking a Clinical Trials Manager for a very important client Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Company therapeutic areas Clinical Operations plays a key role in ensuring all Client clinical trials are performed in accordance with applicable SOPs, company policies and...

  • Clinical Trial Manager

    5 days ago

    San Mateo, California, United States Fladger Associates Full time

    Responsibilities: Excellent employment opportunity for a Clinical Trials Manager in the Foster City area. Hybrid Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all company therapeutic areas. Clinical Operations plays a key role in ensuring all company clinical trials are performed in accordance with...

  • Clinical Trial Manager

    4 weeks ago

    San Mateo, United States Kelly Science, Engineering, Technology & Telecom Full time

    Location: Foster City, CA Contract Length: 6 months, possibility to convert Payrate: $86 per hour 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 therapeutic areas. Clinical Operations plays a key role in...