Job Description
Overview
The Senior Clinical Data Manager is responsible for performing end to end Data Management activities. Participates 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 Clinical Data Manager must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance.
Essential Functions and Responsibilities
- Leads a large clinical study or a series of related studies with minimal guidance
- Represents Data Management at study management team meetings
- Provides mentoring and training to lower-level Data Management staff assigned to his/her studies Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
- Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Performs a thoroughly detailed review of eCRF data requirements and create one if need be.
- Interacts with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- Leads the development of data edit check specifications and data listings
- Coordinates the design and testing of Electronic Data Capture (EDC) systems according to company processes
- Resolves EDC system issues with team members
- Develops or lead the development of the Data Management Plan for a clinical study
- Reviews and provides feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications
- Provides training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
- Performs reconciliation of data from external data sources against the clinical database
- Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Leads database upgrades/migrations including performing User Acceptance Testing
- Performs database lock and freeze activities per company SOPs
- Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business
- Performs miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Bachelor's Degree required in the scientific/healthcare field with 9 years of experience
- Master’s degree with 7 years of experience or PhD with 4 years of experience, preferred
- Must have good project 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.
- Experience in working with oncology studies
- 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.
- Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is 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.
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.
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