Iovance Biotherapeutics
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Clinical Data Manager II [Contract]
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Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Overview
The Clinical Data Manager II will be responsible for assisting the lead data manager in end-to-end Data Management activities. 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 candidate must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with guidance after receiving instructions and / or training The Clinical Data Manager II should be able to:
Essential Functions and Responsibilities
- Ensure the integrity, accuracy and compliance of clinical trial data
- Assist during a study database in RAVE to include but not limited to:
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
- Assist with the development of data edit check specifications and data listings
- Perform User Acceptance Testing (UATs) of Electronic Data Capture (EDC) systems according to company processes
- Assist with the review of migration reports to ensure database build accuracy
- Perform reconciliation of data from external data sources against the clinical database
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Execute data cleaning and discrepancy management to ensure compliance with the protocol
- Track and report study metrics to internal and external stakeholders
- Create or update Data Management Plan (DMP), Data Review Plan (DRP), eCRF Completion Guidelines (eCCGs) and other Data Management required study documents
- Perform database lock and freeze activities per company SOPs
Required Education, Skills, and Knowledge
- At a minimum, Bachelor's degree required in the scientific or healthcare field
- At least 5 years' experience in Data Management for the pharmaceutical / biotechnology industry, or equivalent experience in an FDA-regulated environment including study lead experience
- Oncology experience is a must
- RAVE database experience is preferable
- Must have good time management skills and a proven ability to multitask
- 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.
- Possesses strong English language written and verbal communication skills.
- Able to travel to off-site meetings or training seminars as needed.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
- Experience in Coding (MedDRA and WHODrug), Site and User Management and Lab Normal Range (LNR) entry in Rave is a plus
- Must be able to work collaboratively in a fast-paced environment
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
#LI-remote
The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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Apply to Iovance Biotherapeutics
Senior Director, Clinical Data Management and Analytics
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Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Overview
Senior Director, Clinical Data Management and Analytics, provides leadership to the Clinical Data Management and Analytics Department and provides influence across the Clinical Development organization. As a leader of the Clinical Data Management and Analytics organization, and part of a cross-functional team of drug development scientists focused on providing hands on skills, expertise, and tools to facilitate strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials, in addition to integration, visualization, and exploratory analysis of complex and diverse data in support of clinical development activities and decisions. Through practical hands-on work, the Lead will define approaches, processes, algorithms, and tools that support the analytics, visualizations, and decision support needs of drug development scientists and projects. The Lead will play a key role in building the team with the necessary skills, build relationships with relevant stakeholders, and implement relevant tools and approaches. The Lead will collaborate with Biostatistics leads and other members of drug development teams to ensure connectivity of exploratory analysis work in support of development, regulatory approval, and market acceptance of products. This position includes functional management responsibilities.
Essential Functions and Responsibilities
- Define and implement the overall vision, strategy, and goals for the clinical data management department.
- Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
- Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
- Experience with global trials and regulatory submissions (FDA, EMA).
- Generate novel insights from data and present them via rich and intuitive visualizations.
- Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively across several teams with diverse subject matter expertise.
- Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
- Drives the development and implementation of innovative strategies and technologies.
- Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and build upon existing Iovance standards.
- Provides technical guidance to external partners concerning project and data standards, and analysis practices to ensure efficient and integrated project strategies.
- Identifies opportunities for increased efficiency and consistency within the organization and provides SME support to continuous improvement initiatives.
- Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Performs miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.
- Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
- Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
- Demonstrated ability to lead, motivate, and develop teams.
- Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
- Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
- MS, BS/BA degree, or other suitable qualification with relevance to the field.
- 13 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
- Excellent verbal and written communication skills and strong interpersonal skills are required.
- Demonstrated ability to develop and lead a team of individuals with diverse experience and expertise.
- Ability to explain technically complex information for a non-technical audience.
- Strong positive attitude, thrives in a dynamic, fast paced environment with many simultaneous projects.
- Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
Preferred Education, Skills, and Knowledge
- Experience with AI applications in the data management space is highly desirable.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
#LI-remote
The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
Ready to apply?
Apply to Iovance Biotherapeutics