Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognized as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.

As part of the Global Biometrics department which consists of Data Management, Biostatistics and Statistical Programming. The Senior Manager, Clinical Data Management will be responsible for overseeing a technical team within clinical data management, driving Data Management strategy, and ensure the effective developing and executing data solutions to support Immunocore clinical trials. The candidate will serve as a key member of a multi-disciplinary team to assist with executing the Data Management strategy required for phase 1-4 studies and will play a pivotal role in implementing innovative solutions to streamline data management operations and deliver high-quality data at database build, data cleaning to data review. The Senior Manager has a broad fundamental knowledge of the data management process and can perform key responsibilities independently and/or with minimal guidance.

KEY RESPONSIBILITIES

Lead and manage a technical team within data management (i.e., development SMEs, clinical data programmers). Oversee hiring, mentoring, and professional development to build and sustain a high-performing team.
Provide leadership, direction, and expertise; drive a culture of collaboration and continued improvement; and work closely with other functional leads to maintain cross-functional operational excellence.
Improve the process of clinical database specifications, including eCRF design, user requirements, edit checks, query logic and data validations; oversee the EDC system build, testing, and database release to ensure adherence to regulatory principles.
Collaborate with DM leads and vendors to implement innovative solutions to optimize clinical trial workflow and ability to guide and influence DM team on data management principles and database management principles, vision and strategy.
Collaborate with key stakeholders, including but not limited to Clinical Development, Biostatistics/Programming, and Clinical Operations to improve data collection and quality, representing data management function.
Able to perform independently and/or oversee and be accountable for Data Capture (EDC) systems testing, upgrades, migrations, report production and query management and or CRO (in collaboration with lead data manager) according to company standards.
Manage standards development toward the development and implementation data collection principles in the standard library.
Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs) for study conduct, metric development, and trend monitoring in support technology.
Extract and analyze clinical data using data visualization tools, SAS data listings and or other outputs regularly to identify trends and/or issues to be communicated and addressed with CRO to support IMC study oversight of CRO activities for regulatory compliance.
Ability to provide site and/ or study team training. Assist/Own department management and process development of data review and export tools.
Assist/Own department with development of standards (processes, database, system etc.)
Able to review and provide feedback when required to CROs or study team on other study related documents related to or that have impact to data management related activities. (e.g., Clinical Monitoring Plans, Statistical Analysis Plans and third-party data transfer specs etc.)
Able to review and provide feedback on STDM datasets, formats, mapping.
Perform occasional data review activities of clinical data and/or external data, to help support lead data manager in high quality oversight of data cleanliness and associated activities
Manage Essential Document Management in TMF in a timely manner to maintain regulatory compliance.
Develop or assist with the development of workflow processes and work instructions, improving the efficiency of data management activities at IMC
This position requires 5% domestic and or international travel at the discretion of management.

Experience & knowledge

Experience as Clinical Data Manager and relevant roles at the pharmaceutical/biotechnology industry, or CRO
Demonstrated leadership overseeing DM technical responsibilities and systems to execute DM implementation strategy
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.
Experience in the implementation and management of data review principles and strategies.
Experience in Medidata RAVE, data visualization tools and supporting systems.
Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform core Data Management tasks.
Excellent project management skills and a proven ability to multitask
Attention to detail and the ability to work independently and/ or within a multi-disciplinary team, as well as with external partners and vendors.
Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred.
Possesses 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.

Education & qualifications

Bachelors or Masters in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields.
At least 9 years of directly relevant work experience

Annual salary range for US:
This position is eligible for standard Company benefits, including medical, dental, vision, time off and 401k, as well as participating in Immunocore's annual incentive plans. Incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level.

$149,395 - $162,092
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Immunocore jobs

Senior Manager, Clinical Data Management