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Senior Manager, Data Management

Employer
Neogene Therapeutics
Location
Santa Monica, CA
Start date
Jun 6, 2024

Job Details

At AstraZeneca's Oncology R&D division, 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 and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Senior Manager of Data Management will be responsible for performing/overseeing outsourced Data Management activities that support Neogene clinical trials worldwide. You will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Manager should have a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.

Location: Available in Gaithersburg, MD, New York City, NY, Waltham, MA, or South San Francisco, CA.

Responsibilities

  • Manage and monitor the progress of data management activities with CRO(s) or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
  • Represent Data Management during internal Neogene calls or meetings.
  • Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs).
  • Interact with CRO(s), CRAs, programmers, study managers, statisticians, and any other designated key contributors in designing eCRFs, creating the annotated eCRF, and CRF completion guidelines.
  • Oversee and participate in the development of data edit check specifications and data listings.
  • Coordinate the testing of Electronic Data Capture (EDC) systems according to company standards.
  • Oversee and participate in the development of the Data Management Plan for a clinical study.
  • Able to review and provide feedback to the clinical team on other study documents e.g. safety reconciliation plan and third party data transfer specs.
  • May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
  • Oversee reconciliation of third party data from external data sources against the clinical database
  • Oversee Serious Adverse Event reconciliation activities according to SOPs and guidelines.
  • Oversee and participate in database upgrades/migrations including performing User Acceptance Testing, as required.
  • Oversee, with the Clinical Operation, maintenance of data management files.
  • Coordinate Data Review and conduct Data Review meetings with cross functional study team members to ensure on-going review of study data currency, quality and completeness.
  • Oversee and participate in the database lock and freeze activities per SOPs and timelines.
  • Participate in regular team meetings and provide input when appropriate.
  • Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
  • Assist with the training of new employees and/or contractors, or CROs.
  • Ability to run standard and Ad-hoc reports from clinical study databases as needed by study teams or medical monitors.
  • Other duties as assigned.

Supervisory Responsibilities

  • May manage in-house or contract data management staff as needed.

Education and Experience

  • 8+ years in Pharmaceutical and/or CRO setting with BS/BA in the scientific/healthcare field.; 6+ years with MS/MA or MBA; 3+ years with PhD
  • 5+ years of management experience
  • Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, including study lead experience.
  • Have good project management skills and a proven ability to multitask.
  • Understand the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
  • Possess a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Knowledge of submission requirements preferred (e.g. NDA, BLA and MAA)
  • Experience working with CDISC (SDTM) in data collection preferred.
  • Experience in oncology/hematology drug development is preferred.
  • Extensive experience in managing and collaborating with CROs.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possess solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems.
  • Excellent verbal and written communication and presentation skills.
  • Able to travel to off-site meetings or training seminars as needed.
  • May require occasional evening and/or weekend commitment.

When we put unexpected teams in the same room, we fuel 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.

The annual base salary for this position ranges from $145,000 to $171,000 However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.

Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

DE&I Statement

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.

Company

Neogene Therapeutics is a global, preclinical stage biotechnology company pioneering the development of next generation, fully individualized engineered T cell therapies for a broad spectrum of cancers.

Our proprietary neoantigen T cell receptor (TCR) discovery and T cell engineering platform identifies TCR genes with specificity for neoantigens – found exclusively on cancer cells as a result of cancer-associated DNA mutations.

Cancer is a genetically individual disease – no two tumors are exactly the same. These variations create neoantigens – unique targets for every tumor. Neogene’s novel approach delivers a tailored T cell therapy containing a unique set of specific TCR genes for each individual patient. Engineered into patient-derived T cells, these TCRs are directed toward neoantigens in tumor cells, with the goal of eliciting strong and durable responses in a variety of solid tumor indications.

We offer the opportunity to join a highly dynamic biotech start-up. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Company info
Website
Location
2225 Colorado Avenue
Santa Monica
CA
90404
United States

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