Clinical Trial Specialist

Abbott Laboratories San Diego , CA 92140

Posted 1 week ago

DO WORK THAT MATTERS.

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Clinical Affairs Specialist, Competitor Product Test Lab is within our Infectious Disease Developed Markets located at San Diego. In this role you will have minimal supervision, be responsible for the coordination, management and monitoring of analytical or clinical studies undertaken by the company in support of research, marketing/sales, and regulatory objectives. This job requires in-depth experience and capability of competitor product comparison study management.

RESPONSIBILITIES:

  • Lead all operational aspects of competitor studies for which he/she is responsible for.

  • Participate in site selection and initiation activities, and drive confidentiality agreement, site qualification, budget negotiation and contract.

  • Draft protocols for company supported studies with input from technical, regulatory, quality assurance, and marketing personnel and, as appropriate, regulatory agencies.

  • Deliver study materials in a timely fashion (e.g., Reagents, Consumables, Instruments, Software, Sample Transport Systems, etc.)

  • Actively monitors status of communications with clinical study sites

  • Maintains and manage clinical study activities in database systems, consistent with company timelines and objectives

  • Constructs and audit data files

  • Supports all clinical affairs activities as needed .

  • Travel is expected to be around 30%. Travel to sites for study initiation, training and assessment of research study team activities.

  • Perform other duties & projects as assigned.

BASIC QUALIFICATIONS:

  • Master's Degree in Chemistry, Biology, or other related Science field.

  • 3+ years' experience in clinical study research and/or in biotechnology or related industry.

  • Prior experience managing product performance evaluation studies or within the biotech or device industry. Point-of-care industry experience is a plus.

PREFERRED QUALIFICATIONS:

  • In-depth knowledge of infectious disease competitive landscape and products.

  • Strong technical background and capable of analyzing product specification, performance aspects and limitations.

  • Ability to perform scientific analysis to assess current publications.

COMPETENCIES:

  • Drive for results and thrive in a fast paced environment.

  • Strong interpersonal skills and ability to interact at all levels with sensitivity and tact.

  • Strong organizational skills, with attention to details.

About Abbott.

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accomodation to qualified individuals with disabilities. To request accomodation, please send an email to MyRecruiter@alere.com.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Trial Assistant

Xencor, Inc.

Posted 7 days ago

VIEW JOBS 10/16/2020 12:00:00 AM 2021-01-14T00:00 Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics - antibodies and other proteins with improved function - with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Clinical Trial Administrator to join our team. Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing. The successful candidate will be an experienced, self-motivated Clinical Trial Assistant (CTA) to support the day-to-day activities of the assigned Clinical Trials. Job Duties include: * Assist the Clinical Trial Manager (CTM) to prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA 21CRF essential study documents. Inform the CTM/Clinical Team on any outstanding document/s * Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests * Develop and maintain tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs * Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders * Day-to-day contact with counterpart at outside Vendor, CRO and/or trial site; daily review and identification of potential issues or problems and communicates/escalates to CTM/Clinical Team * Tracking of patient and recruitment status using applicable spreadsheets and web portal tools * May assist in the review of key study documents (eg, Protocol, ICF, study plans, eCRF) Qualifications/Requirements: * Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively * Ability to establish and maintain effective working relationships with coworkers, managers and clients * Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint * Strong oral and written communication skills * Basic awareness of clinical trial regulations and processes * 1-2+ years required (CTA). Study coordinator from CROs or academic institutions will be considered * High school diploma (required); BA/BS degree in life sciences or similar field (preferred) We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume to recruiting@xencor.com. For further information about Xencor, please visit our website at www.xencor.com EOE Xencor, Inc. San Diego CA

Clinical Trial Specialist

Abbott Laboratories