Clinical Data Manager - Contract (Onsite 3days/wk)

Jasper is a clinical-stage biotechnology company developing briquilimab, a novel antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU and is initiating a clinical study in patients with asthma. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU, and as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).

• Oversee the collection, validation and processing of clinical trial data.
• Develop and implement data management procedures for clinical trials.
• Support and facilitate the review of medical coding for validity and completeness.
• Ensure compliance with applicable regulations, protocols and standard operating procedures in India.
• Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
• Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management.
• Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
• Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
• Perform data entry and cleaning activities, including discrepancy management and query resolution.
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
• Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
• Collaborate with study team members and external vendors, CRO to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for clinical study reports.
• Serve as a primary or backup resource for issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.  

• Bachelor’s degree in a scientific or healthcare-related field.
• 7-10 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
• Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
• Proficiency in electronic data capture (EDC) systems and clinical data management software (e.g. RAVE, Medrio, Veeva).
• Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
• Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Excel tools.
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organizational and time management abilities.

• SAS programming and certification in clinical data management (like CCDM) a plus.
• Knowledge of CRF design, MS Project and analytical capabilities a plus.
• Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM) a plus.
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
• Understanding of data privacy and protection regulations (e.g., GDPR).
• Effective communication and interpersonal skills to collaborate with other teams

Jasper is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

Company Values:

·       Respect

·       Collaboration

·       Integrity

·       Responsible

·       Excellence

·       Acknowledgment

Mission:

Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision