Clinical Supplies Manager

Icon San Francisco , CA 94118

Posted 3 weeks ago

This is an exciting opportunity to join ICON

Clinical Supply Manager

Location: home or office based

At ICON, it's our people that set us apart.

Are you a seasoned Clinical Supply Manager with global experience in all phases of pharmaceutical development with respect to technical, quality, timing and cost? Are you passionate to join a leading CRO?

As a Pharmacy Manager at ICON, you'll be working within our newly formed Clinical Supplies Services group, responsible for global pharmaceutical supply for all phases and pharmaceutical development activities.

The role

  • Oversee supply and pharmaceutical development activities, with respect to technical, quality, timing and cost standpoint on behalf of the client

  • Interact closely with other ICON divisions and clients as part of the project team

  • Provide guidance to IMP management, supply strategies, supply demand planning and forecast, dosing, dispensing and formulation considerations

  • Advise, prepare and review study specific procedures, IP Management Plans and Dosing Instructions and agreement for all aspects of IP supply activities

  • Generate IP manuals, to support use of the IMP at clinical sites

  • Ensure necessary training in the receipt, storage, handling and preparation of IMP, as appropriate

What you need:

  • Bachelor's degree, licensed Pharmacist desirable

  • Clinical supply management experience, including knowledge of GMP/GDP/GCP, global regulatory requirements relating to pharmaceutical and clinical supplies

  • Able to demonstrate experience in the evaluation and procurement of marketed drug product

  • Previous experience in manufacturing operations, batch record review and approval

  • Client facing experience, ensuring our delivery meets the project expectations and coordinating regular meetings to update the client on the project status

Benefits of Working in ICON:

ICON provides Pharmacy Manager's with the innovative resources to be successful in delivering results, inspiring others and becoming a trusted partner. We offer an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, management bonus plan, significant time away from work, and many other incentives amongst an opportunity to grow your career within ICON.

What's Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

Benefits of Working in ICON :

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.

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

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 Manager / Senior Clinical Trial Manager

Ideaya Biosciences

Posted 1 week ago

VIEW JOBS 10/19/2020 12:00:00 AM 2021-01-17T00:00 <p><strong>About IDEAYA Biosciences:</strong></p><p>IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response.</p><p>IDEAYA recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see <a href="" rel="nofollow noreferrer noopener" class="external"></a>.</p><p><strong>Position Summary:</strong></p><p>IDEAYA is seeking a talented and highly motivated Clinical Trial Manager/Senior Clinical Trial Manager of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for providing leadership to Study Execution Team (SET) and oversight of clinical trials for IDEAYA’s early stage clinical programs.</p><p>As a Clinical Trial Manager/Senior Clinical Trial Manager, you will work directly with Medical Monitor and other cross-functional representatives including Clinical Data Management, Regulatory, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills, learn new skills and play a key role in clinical trial planning and execution. As a member of our dynamic group, you will help to grow IDEAYA’s pipeline.</p><p><br></p><p><strong>What you'll do:</strong></p><ul> <li>Lead SET to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines</li> <li>In collaboration with SET, develop and facilitate Request for Proposals, review proposals and contribute to selection of Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit</li> <li>Be accountable for the management of CRO and other clinical vendors to ensure that project and Corporate goals are achieved on time and within budget</li> <li>Write or contribute to preparation of clinical documents (e.g., protocols, informed consent forms, case report forms, study reference manuals, study plans)</li> </ul><ul><li>Partner with Clinical Development and CRO colleagues for clinical trial planning</li></ul><ul><li>Lead study activities including investigator selection, study start-up, recruitment, data collection and review, and monitoring oversight</li></ul><ul><li>Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT</li></ul><ul><li>Provide quality oversight to ensure inspection readiness</li></ul><ul> <li>Review and track key study metrics and progress reports; identify barriers to timely and successful trial execution and propose creative solutions</li> <li>Establish and maintain strong relationships with internal cross-functional teams, CROS and vendors, and clinical research site personnel for successful execution of clinical trials</li> </ul><ul><li>Train investigators and site staff, vendor staff and team members on study protocol and trial conduct processes</li></ul><ul> <li>Develop and revise SOPs and work instructions, and participate in building of department infrastructure as needed</li> </ul><p><strong>Requirements</strong></p><p><strong>AKA what you will bring:</strong></p><ul> <li>Bachelors in life sciences or related discipline with 4-6 years of experience in clinical and drug development</li> <li>Clinical study management and vendor management experience in oncology</li> <li>Early phase oncology trial management experience preferred</li> <li>Excellent knowledge of FDA and ICH/GCP regulations and guidelines</li> <li>Self-motivated and takes pride in your work</li> <li>Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships</li> <li>Detailed oriented and creative thinker with a passion for process optimization</li> <li>Excellent organizational and communication skills</li> <li>Analyze and triage problems, prioritize accordingly, and propose solutions</li> <li>Ability to travel as required (approximately 20%)</li> </ul><p><strong>Benefits</strong></p><p>When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.</p><p>IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets</p> Ideaya Biosciences South San Francisco CA

Clinical Supplies Manager