Senior Manager, Data Management

Found in: beBee jobs US - 7 days ago

Santa Monica, California, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values 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.

Position Summary

The Senior Manager of Data Management will be responsible for performing/overseeing outsourced Data Management activities that support Neogene clinical trials worldwide. He/she 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.

Essential Functions and 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.

Required Skills/Abilities
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.

Education and Experience
BA/BS, preferably in the scientific/healthcare field.
At least 6+ Years of experience in Pharmaceutical and/or CRO setting.

The anticipated salary range for candidates who will work in Santa Monica, CA is $145,000 to $171,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

Note: At this time, Neogene is not sponsoring VISAs.

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

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
A collaborative culture that leverages the diverse perspectives of employees and supports courage
Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."

  • Senior Catering Manager

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States Hilton Santa Monica Full time

    Exciting opportunity for an energetic catering sales professional in the Santa Monica market who can appreciate representing an upscale, luxurious hotel. Hilton Santa Monica Hotel & Suites is searching for an experienced & dynamic Senior Catering Manager, to represent the hotel. Must have a proven track record that demonstrates passion & ability to drive the...

  • Senior Data Scientist

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States Metropolis Technologies Full time

    Location: Santa Monica, CA, Seattle, WA, or New York City, NY (Hybrid) The CompanyMetropolis develops advanced computer vision and machine learning technology that makes mobile commerce remarkable. Our platform is already deployed in hundreds of mobility facilities and industries with billions in opportunity. We're building the digital pipes through which...

  • Senior Product Manager

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States MediaLab Full time

    MediaLab is a media & technology company focused on acquiring and growing properties and global brands. The organization is a unique combination of private equity, holding company and operating entity. We continue to expand and are proud of the prominent market position of our brands. Come join an exceptionally talented team of engineers, designers, product...

  • Product Manager, Software

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States Tixr Full time

    TIXR is a leading ticketing technology company and exclusive partner with some of the largest Live and Virtual Events, festivals and venues, monetizing through event ticketing, merchandise, food & beverage, and hotel hospitality for passionate fans around the world. About The Position:As a Product Manager you will be part of a growing team that is building...

  • Channel Manager

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States Poppin Full time

    Responsibilities Develop and nurture relationships at all levels within A&D accounts including Principals Business Development Studio Heads Design Directors Designers Project Managers and Resource Librarians Become part of the A&D community through educational library updates lunch & learns showroom presentations relationship building lunches dinners and...

  • Bar Manager

    Found in: beBee jobs US - 1 week ago

    Santa Monica, California, United States The Georgian Hotel Full time

    Job SummaryThe Bar Manager is responsible for managing the bar operations including the Sunset Bar and Georgian Room restaurant. This person should have experience curating elevated bar programs. This includes creating cocktail recipes and training the bar team on production of drinks. Prepares and serves alcoholic or non-alcoholic beverages to customers or...

  • Accounting Manager

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States World Surf League Full time

    The Accounting Manager serves as a key member of the Finance Team assisting the growing department and reporting into the Controller, Director of Accounting. This role will have a focus in Regional Reporting and will act as the liaison with all Regional offices to ensure proper subsidiary reporting. This role will also have a focus in Revenue Accounting and...

  • Clinical Research Data Associate III

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States Cedars-Sinai Full time

    Job DescriptionDescription The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons,...

  • Account Manager, Supporter Ticketing

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States teamworkonline Full time

    Angel City is building a world-class organization to support its ambitions to redefine sports and entertainment. We aspire to be a global brand to have the most significant impact, drive the largest awareness, and deliver returns from our soccer club and beyond. We lead with purpose and passion, building a new type of company and a new type of club. We do...

  • Account Manager, Supporter Ticketing

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States tapwage Full time

    Angel City is building a world-class organization to support its ambitions to redefine sports and entertainment. Our vision is to create engaging and unique content across multiple platforms to bring the purpose-driven mission of this Club to the world.We are stronger together, have more impact together, and have more fun togetherAngel City is looking for an...

  • Accounting Manager/Sr. Manager/Director@ Boutique Management Consulting CFO + Accounting Firm

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States Wells Group of New York Full time

    This role is the equivalent level to a Controller at a small company. Depending on your experience, this role could be titled "Accounting Manager, Controller Practice", "Sr Accounting Manager, Controller Practice" or "Director, Controller Practice" ABOUT THE COMPANY:We are seeking a Controller with 7-10 years of experience to join our team. Wells Group of...

  • Partner Marketing Manager

    Found in: beBee jobs US - 2 weeks ago

    Santa Monica, California, United States Recharge Payments Full time

    OverviewToday, much of our business is managed through our partner ecosystem, a group of service and technology partners that lead their own successful programs with merchant customers that integrate and partner with Recharge. The Partner Marketing Manager will design and execute demand generation programs and marketing campaigns with and for the Recharge...

  • Clinic Manager

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States UCLA Health Full time

    In this role, you will oversee the business and patient care functions of the assigned UCLA Health Community Clinics. Supervise the medical front and back office staff and coordinate clinical services. Provide daily administrative and operational oversight and physical space management.Salary range: $31.03/hr - $65.90/hrQualificationsRequired: Demonstrated...

  • Catering Manager

    Found in: beBee jobs US - 3 days ago

    Santa Monica, California, United States Hilton Santa Monica Full time

    Exciting opportunity for an energetic catering sales professional in the Santa Monica market who can appreciate representing an upscale, luxurious hotel. Hilton Santa Monica Hotel & Suites is searching for an experienced & dynamic Catering Manager, to represent the hotel. Must have a proven track record that demonstrates passion & ability to drive the...

  • Store Manager

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States Crate & Barrel Full time

    Hudson Grace is the preeminent purveyor of timeless décor for those who love to entertain. Rooted in a philosophy of simplicity and authenticity, we favor beauty and practicality in our curated collection of quintessentially modern serving ware, dinnerware, glassware, flatware, linens, candles and entertaining essentials. Hudson Grace crafts and sources...

  • Senior Software Developer

    Found in: beBee jobs US - 7 days ago

    Santa Monica, California, United States Hailo Full time

    What You'll Do Lead design and architecture of our robust and scalable payments platform Building and implementing a large-scale and real-time data process using Spark/Hadoop. Serve as a catalyst for leading Agile transformation on the team Work closely with Product owners and Technical program managers Use a mix of technologies including Scala, Kotlin and...

  • Assistant Study Coordinator, Orthopaedic Surgery

    Found in: beBee jobs US - 1 week ago

    Santa Monica, California, United States UCLA Health Full time

    The Assistant Clinical Research Coordinator assists the Clinical Research Coordinator and/or Senior Clinical Research Coordinator in contributing to the overall operational management of clinical research/trial/study activities. You recognize and perform necessary tasks to assist the Clinical Research Coordinator and/or Senior Clinical Research Coordinator...

  • Senior Business Strategy and Pricing Manager

    Found in: beBee jobs US - 7 days ago

    Santa Clara, California, United States Infoblox Full time

    Description It's an exciting time to be at Infoblox. Named a Top 25 Cyber Security Company by The Software Report and one of Inc. magazine's Best Workplaces for 2020, Infoblox is the leader in cloud-first networking and security services. Our solutions empower organizations to take full advantage of the cloud to deliver network experiences that are...

  • Senior Manager

    Found in: beBee jobs US - 7 days ago

    Santa Clara, California, United States Connor Group Full time

    Connor Group has several offices with hybrid work arrangements. We are also hiring remote professionals for this position.Are you an intellectually curious, deal oriented professional who enjoys coming up with innovative solutions to complex business issues? Connor Group is seeking professionals who want to build off their existing accounting, operational,...

  • Senior Firmware Manager

    Found in: beBee jobs US - 2 weeks ago

    Santa Clara, California, United States Geli Full time

    Hanwha Q CELLS Co., Ltd., is one of the world ́s largest and most recognized photovoltaic manufacturers for its high-performance, high-quality solar cells and modules.Hanwha Q CELLS is a flagship company of Hanwha Group, a FORTUNE Global 500 firm and a Top 7 business enterprise in South Korea.Our mission is to provide affordable and smart energy solutions...