Job Description
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
SUMMARY:
Position – Senior Clinical Data Manager
Who Will Love This Job
A seasoned, self-motivated clinical data manager who enjoys performing the day-to-day tasks of clinical data sciences.
A team player who is goal-oriented and has strong leadership skills to collaborate with cross-functional clinical data teams, including CRO and vendor partners, to achieve results on clinical data sciences timelines and deliverables.
An experienced clinical researcher who can work independently to decipher complex clinical trial protocols, identify the clinical data required for the analysis of the study and align to appropriate clinical data standards (e.g., CDISC, CDASH).
An experienced clinical data scientist with expert knowledge in the identification, set-up, testing and management of various electronic clinical trials data systems.
An excellent communicator with a strong work ethic who thrives in a dynamic, high growth, entrepreneurial environment.
RESPONSIBILITIES:
Lead and organize the technology systems strategy in collaboration with preferred vendors to support the timely and efficient delivery of global development programs with high quality and within allocated budget
Strategic planning, resourcing, oversight of data deliverables including design and implementation of data capture tools, data processing, coding, validation, data quality
Develops, implements and oversees an operational data ownership strategy in support of global development projects for all therapeutic areas
Data standards development and adherence including guidance on data continuum; drives strategy to ensure compliance with CDISC standards for all development programs to ensure regulatory submission compliance
Creation of timelines consistent with departmental and corporate goals and ensure all deliverables and milestones are met
Represent data management and effectively communicate requirements, strategy, metrics, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
Create and produce in-process data reports to facilitate decision-making on clinical trials (eg safety reviews etc.)\
Review and provide input as necessary to clinical protocols/amendments, clinical study reports, statistical analysis plans etc.
Ensures the clinical data/statistical programming vendor’s technology processes meet or exceed the regulatory requirements to support global development projects
Responsible for planning and management of external budgets related to data technology licensing, hosting and deliverables
Technical oversight of other technologies (e.g. IRT, EDC, ECG, ePRO, etc.)
Develop clinical data management documents for clinical trials and execute data transfer plans for external data. Set up validated automated data flows and relays for data receipt through archive.
Establish clinical data solutions and science infrastructure, including the identification, set-up, testing and management of various electronic clinical trials data systems.
Collaborate with internal and external stakeholders to ensure the quality and integrity of clinical data and data systems.
Support GCP inspection readiness in all data management related domains
Establish best practices and develop data management SOPs and processes as required
QUALIFICATIONS:
Bachelor’s/MS Degree, a minimum of 4 years’ experience in clinical data management within a pharmaceutical or biotech environment.
Expert knowledge in multiple vendor’s clinical electronic data capture systems and other clinical data systems
Experience in effectively managing CROs and other technical partners.
Proficient in regulatory requirements for data management and the regulatory submission process. Pre-IND, as well as NDA and/or BLA filing/submission experience is highly desirable.
Able to prioritize activities, manage timelines and work effectively and collaboratively in a fast-paced environment. Strong project management skills with demonstrated experience to manage multiple priorities while maintaining attention-to-detail, curiously solve complex problems and meet timelines.
Must be self-motivated, highly organized, detail-oriented and able to multi-task while delivering high quality work
Work well in cross functional team environment, both independently as well as be willing to help others
Requires excellent interpersonal skills including the ability to influence and to work effectively cross-functionally.
Strategic agility, strong critical and logical thinking with ability to analyze problems
Excellent presentation and written/verbal communication skills
Previous experience completing multiple complex clinical studies in oncology, CNS, and/or Rare. Proven experience in the design, execution, and interpretation of first-in-human studies and proof-of-concept trials. Phase I-III experience preferred including IND and NDA filings.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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