Clinical Vendor Outsourcing associate

3 weeks ago


San Mateo, United States Intelliswift Software Inc Full time

Title: Clinical Contracts Associate I (VQ Associate I)

Location: Foster City

Duration: 12 Months on W2

Hybrid: 3 days a week minimum

Details:

The candidate should have a deep understanding of vendor outsourcings responsibilities throughout the vendor sourcing, contracting, and management processes as they will be reviewing VOs functional responsibilities in support of the clinical development portfolio. Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.

Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VOs electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VOs documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.

The role also involves coaching VO team members to resolve issues from a QC standpoint and serving as a primary reviewer of QC data for inspection readiness.

The VO QC Specialist is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.

Demonstrates a thorough knowledge of Good Clinical Practice GCP, Good Pharmacovigilance Practices GVP, Good Laboratory Practice GLP, Good Documentation Practice GDP and ICH E6 R2 compliance requirements.

Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries

Skills:

Strong interpersonal communication skills

Attention to detail and proactive management of quality findings will be integral to the teams success

Strong project management, organization, and critical thinking skills

Comfortable interacting with internal stakeholders and external vendors

Executive presence



  • San Mateo, United States The Fountain Group Full time

    Location: Foster City, CA 94404Overview: Supply Chain Manager is an enthusiastic team player who will provide expertise in a fast-paced pharmaceutical clinical supplies environment for company's global clinical trials. This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate...


  • San Mateo, United States LanceSoft Full time

    Contract Negotiation Clinical Development. Clinical Development Process, Sourcing in. Pharmaceutical/ Regulated environment. Supporting various activities and projects within the Vendor Outsourcing organization mainly for Clinical Trial / Operations Outsourcing. Contract execution, review, management, routing and quality control. Management of MSAs, WOs,...


  • San Mateo, United States LanceSoft Full time

    Contract Negotiation Clinical Development. Clinical Development Process, Sourcing in. Pharmaceutical/ Regulated environment. Supporting various activities and projects within the Vendor Outsourcing organization mainly for Clinical Trial / Operations Outsourcing. Contract execution, review, management, routing and quality control. Management of MSAs, WOs,...


  • San Mateo, United States ACL Digital Full time

    Title : Manager, Clinical Contracts & Finance – III Locations: FC, NJ, Santa Monica, CA (Hybrid)Contract roleDescription: Candidate can be based in either FC or NJ or Santa Monica locations Client is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you...

  • Associate Director

    3 weeks ago


    San Mateo, United States The Fountain Group Full time

    Job Description: Pay is 100-139/hr based on experience to start. Hours start off at 32 hours/ week, Mon-Thurs, or Tues-Fri, after 2 months, position will become 40 hrs/ week, Mon- Friday, regular business hours. Position is initially an 8-month contract, highly likely to extend or convert permanent. Advance the understanding of laboratory data in support of...


  • San Diego, United States Equillium, Inc. Full time

    Overview of Position: Managing and meeting the objectives of clinical studies and programs by ensuring successful conduct of assigned clinical programs consistent with applicable regulations, Good Clinical Practice (GCP) and current standard operating procedures (SOPs). Accountable for meeting clinical study and milestones within scope and budget. Interface...


  • San Mateo, United States Collabera Full time

    Candidate can be based in either Foster City, CA or NJ or Santa Monica locationsCore Responsibilities:Delivery Excellence:Develop a comprehensive global clinical development vendor strategy for Cell Therapy programs or therapeutic areas.Lead contract and sourcing activities for Phase 1b-3 clinical development programs, ensuring consistent customer service...


  • San Mateo, United States Collabera Full time

    Candidate can be based in either Foster City, CA or NJ or Santa Monica locationsCore Responsibilities:Delivery Excellence:Develop a comprehensive global clinical development vendor strategy for Cell Therapy programs or therapeutic areas.Lead contract and sourcing activities for Phase 1b-3 clinical development programs, ensuring consistent customer service...


  • San Mateo, United States Collabera Full time

    Candidate can be based in either Foster City, CA or NJ or Santa Monica locationsCore Responsibilities:Delivery Excellence:Develop a comprehensive global clinical development vendor strategy for Cell Therapy programs or therapeutic areas.Lead contract and sourcing activities for Phase 1b-3 clinical development programs, ensuring consistent customer service...


  • San Diego, United States Equillium Full time

    Overview of Position:Managing and meeting the objectives of clinical studies and programs by ensuring successful conduct of assigned clinical programs consistent with applicable regulations, Good Clinical Practice (GCP) and current standard operating procedures (SOPs). Accountable for meeting clinical study and milestones within scope and budget. Interface...


  • San Mateo, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis...


  • San Diego, United States Equillium Full time

    The Clinical Trial Associate (CTA) is responsible for assisting with clinical operations activities or projects and will interact and collaborate with the Clinical Operations team and may interact with study vendors and/or clinical study sites. The CTA supports the timely conduct of clinical studies per study protocols, Good Clinical Practice (GCP), Standard...


  • San Diego, United States Candid Therapeutics Full time

    **Company Overview**: Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients’ lives by advancing novel therapies to address unmet medical needs. **Position Overview**: As the Head of Clinical Operations, you will be a key leader in the company, responsible for overseeing all aspects of...

  • Clinic Administrator

    3 weeks ago


    San Mateo, California, United States Massage Envy Full time

    Clinic Administrator for busy membership massage clinic needed to manage daily operations.Duties include: Oversee and manage the daily operations of the clinic. Assist Franchise Owner in setting all membership and retail sales goals. Responsible for achieving all membership and retail sales goals. Manage sales associates and massage therapy staff. Trains,...

  • Research Associate I

    3 weeks ago


    San Mateo, United States R&D Partners Full time

    R&D Partners is seeking to hire a Research Associate I in South San Francisco, CA. Your main responsibilities as a Research Associate I:The successful applicant will be responsible for the design, generation, archiving, and distribution of RNA-based Research Associate, Associate, Clinical Research, Research, Technology, Staffing

  • Clinical Data Manager

    4 weeks ago


    South San Francisco, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors...


  • South San Francisco, United States Arsenal Biosciences Full time

    ArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Associate Director, Clinical Business Operations to work hybrid or remotely.ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products...

  • Clinic Administrator

    4 weeks ago


    San Mateo, United States Massage Envy Full time

    Clinic Administrator for busy membership massage clinic needed to manage daily operations. Duties include: Oversee and manage the daily operations of the clinic. Assist Franchise Owner in setting all membership and retail sales goals. Responsible for achieving all membership and retail sales goals. Manage sales associates and massage...


  • San Antonio, United States The Bank of San Antonio Full time

    Job Type Full-timeDescriptionPosition Summary:Our community bank is seeking a highly motivated and detail-oriented individual to join our team as a Vendor Relationship Manager. This individual contributor will manage our Vendor Relationships. As the Vendor Relationship Manager, you will be responsible for leading the Vendor Management program and framework....


  • San Diego, United States VENTYX BIOSCIENCES, INC. Full time

    Description Ventyx Biosciences, Inc. is a clinical-stage, public biopharmaceutical company focused on advancing new therapies for millions of people living with inflammatory diseases and autoimmune disorders. We are developing novel and differentiated therapeutics that target both the innate and adaptive immune system. Our clinical-stage programs include an...