Bioanalytical Operations/ Project Manager Lead in Clinical Trials Bioanalysis & Study Management
AstraZeneca

Job Info

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Do you have a passion for keeping complex operations running smoothly? We are seeking a skilled and motivated scientific bioanalytical project manager to join our group within Integrated Bioanalysis. We have a diverse team of scientists working across many programs/studies and technologies to provide high quality, decision-driving data.

You will be located at our research hub in Gaithersburg Maryland.

This position will manage bioanalytical operations in support of clinical trials that involve co-ordination of activities between multiple stake holders internal and external to AZ to ensure timely delivery of quality bioanalytical data. Focus will initially be on real-time testing of perishable samples for flow cytometry applications, but will likely expand to include PK, ADA, Nab, and other biomarker data that can come from variety of technologies. You will work with experienced project representatives, subject matter expert scientists, and the clinical trials teams including clinical operations, data management, and business operations functions to implement and maintain validated bioanalytical assays at third-party laboratory vendors. Duties will include managing timelines, communications, sample testing monitoring throughout the life of studies, assisting with data transfers and completion of bioanalytical study reports, delivery of cleaned data sets for interpretive analysis that are suitable for inclusion in clinical study reports.

What you'll do:

• Manage contracting with third-party lab service providers for assay development and validation, and work with business operations, procurement, and clinical operations to ensure appropriate SOWs and contracts are put in place for sample analysis of clinical trials samples.

• Coordinate with bioanalytical strategy leads, clinical trial teams and third-party lab service providers to review, edit, and finalize study documents for delivery of the required lab services and ensure study timelines are met.

• Provide input into clinical trial related documentation such eCRFs, ICFs, SOWs, sample collection instructions.

• Work with data BSLs, data management, programmers to drive delivery of data transfer specifications and the associated data.

• Manage sample tracking and logistics for sample testing, contribute to solving any sample reconciliation issues.

• Address issues that arise in data transfers and drive cleaning and reconciliation of the data for data finalization

Education required:

- BA/BS or higher degree with a background in medical science or relevant scientific background

BA/BS and 4+ years of clinical trial management or

MS and 2+ years of clinical trial management

Experience required:

- Demonstrated experience in developing/validating bioanalytical and/or biomarker assays to support clinical trials (PK, ADA, Nab assays and biomarkers).

- Familiar with clinical bioanalysis outsourcing operations across a range of technology platforms, including real-time Flow Cytometry.

- Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and AstraZeneca expectations.

- Experienced in GLP, GCP guidelines and environment, vendor audits.

- Familiar with clinical trials design with an ability to read a clinical study protocol and understand the study design and data outputs (i.e., dosing regimen, cohort requirements, secondary and exploratory data outputs, schedule of assessments etc.)

- Experienced in handling and providing sample collection instructions and review and provide input into lab manuals regarding sample collections.

- Familiar with data transfer agreement/specifications.

- Basic understanding of reconciliation (sample and data)/cleaning of clinical data and generating queries for resolution.

- Ability to support project resourcing and project timeline planning, negotiation with CROs and stake holders on timelines to gain alignment, and adherence to timelines.

- Good written/ verbal communication skills with a strong command of English language and grammar; excellent organizational, analytical/problem solving skills and attention to detail.

- Strong interpersonal communication skills and the ability to work and collaborate effectively on cross-functional teams.

- Ability to work productively in both a team environment and independently as needed.

- Proficiency with Excel and/ or other interactive computer programs.

Desirable for the role

- Familiarity with flow cytometry datasets a plus but not required.

- Advanced data analysis skills (spotfire, JMP and other) desirable.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Join us in Biopharmaceuticals R&D and be part of a dedicated Research & Development team. Strengthen our pipeline to make a meaningful impact on patients. This is the place to go beyond discovery. We think holistically about patients and are always learning from those living with diseases. We harness digital, data science & AI to fast-forward our research. Making sure work born in a lab can make a real difference. Everyday, impacting patients' lives across the world.

Ready to make a difference? Apply now and join us in our mission to improve the lives of patients through life-changing medicines!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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