Job description

Clinical Data Specialist

Rockville, Maryland, United States

CLINICAL DATA SPECIALIST 
Rockville, MD or Conshohocken, PA

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

This position is located in Rockville, MD or Conshohocken, PA.

 

The Role:

The Clinical Data Specialist will be responsible for performing/overseeing outsourced Data Management activities that support Immunocore clinical trials worldwide. He/she will participate as an active member of a multidisciplinary team to assist with executing the Data Management tasks required for phase 1‐4 studies, study oversight and general data and document management. The Clinical Data Specialist has a broad fundamental knowledge of the data management process and can perform key responsibilities with minimal guidance.

Key Responsibilities:

  • Assist lead data manager to 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.
  • Assist lead data manager with quality data review for scheduled comprehensive CRO oversight of identified study review (i.e., DRP and DMP) specifications and reconciliation parameters (i.e. SAE Reconciliation, lab data review) and data quality (i.e. P21 report review).
  • Participate in clinical study teleconferences and in person meetings to represent data management and provide respective updates.
  • Support lead data manager to 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.
  • Assist lead data manager with creating, updating, and issuing data management study specific documentation in line with study activities.
  • 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.
  • Assist department management and process development of data review and export tools.
  • Assist department with development of standards (processes, database, system etc.).
  • Interact with CRO(s), CRAs, programmers, study managers, statisticians, and any other designated key contributors during all phases of conduct of a study to meet defined department goals.
  • Assist with and learn various Electronic Data Capture (EDC) systems to assist with testing, upgrades, migrations, report production and query management to lead data manger and or CRO (in collaboration with lead data manager) according to company standards.
  • Able to review and provide feedback to lead data manager 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.
  • May aid or provide training to internal study team members on Agiloft and/or Netsuite processes.
  • Responsible for department processing of contracts and invoices.
  • 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.
  • Lead the data management oversight of the TMF, with the CTM, maintenance of data management files and perform consistent quality checks of the TMF to ensure data management related documents are filed in a timely manner to maintain regulatory compliance.
  • Assist in the database lock and freeze activities per SOPs and timelines.
  • Develop or assist with the development of workflow processes and work instructions, improving the efficiency of data management activities at IMC.

Experience & Knowledge: 

  • At least 3‐5 years of directly relevant work experience.
  • Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, including study lead experience.
  • Has good project management skills and a proven ability to multitask.
  • Understands 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.
  • Possesses 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.
  • Attention to detail and the ability to work individually, 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. Experience with InForm and Rave is preferred.

Education:

  • BA/BS, preferably in the scientific/healthcare field.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.   

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

 

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