About MapLight Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
Palo Alto, CA, US
$145K - $160K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 9 days ago
Job description
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You'll Do:
We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the integrity, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products.
Responsibilities:
Qualifications:
Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA or Redwood City, CA.
MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
Salary Range
$145,000-$160,000 USD
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
What You'll Do:
We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the integrity, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products.
Responsibilities:
- Manage and lead all aspects of clinical trial data management activities from study start-up to database lock.
- Develop and implement data management plans, data validation plans, edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs.
- Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle.
- Oversee Medidata Rave electronic data capture (EDC) system setup, configuration, user management, coding and data extracts.
- Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock.
- Conduct periodic data reviews and generate weekly data quality metrics to identify trends and outliers.
- Identify Protocol Deviations
- Produce medical monitor, coding listings and ad hoc listings for team review (Jreview, SAS, Business Objects).
- Participate in the development and review of clinical study protocols, case report forms (CRFs), and clinical trial documentation.
- Provide support for regulatory submissions, audits, and inspections related to clinical trial data management.
- Stay current with industry standards, best practices, and regulatory requirements related to clinical data management.
Qualifications:
- Bachelor's degree in life sciences, computer science, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
- Proficiency in Medidata Rave electronic data capture (EDC) system..
- Strong understanding of Good Clinical Practice (GCP) guidelines, regulatory requirements (e.g., FDA, EMA), and industry standards (e.g., CDISC).
- Excellent communication, organizational, and problem-solving skills.
- Ability to work effectively in a fast-paced, cross-functional team environment.
- Attention to detail and commitment to data quality and integrity.
Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA or Redwood City, CA.
MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
Salary Range
$145,000-$160,000 USD
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
maplightrx.com
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Clinical Data Manager?
A: To succeed as a Clinical Data Manager, key technical skills include proficiency in Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC) systems, and data management software such as SAS or R. Additionally, strong domain-specific skills in clinical research regulations, Good Clinical Practice (GCP), and data validation are essential.\n\nSoft skills that contribute to success in this role include strong organizational and time management skills, effective communication and collaboration with cross-functional teams, and attention to detail and analytical thinking to ensure data accuracy and integrity. These strengths enable Clinical Data Managers to efficiently manage large datasets, identify and resolve data discrepancies, and maintain compliance with regulatory requirements.\n\nBy possessing these technical and soft skills, Clinical Data Managers can effectively oversee data collection, cleaning, and analysis, ultimately supporting the success of clinical trials and contributing to the growth of their careers in the pharmaceutical or biotechnology industry.
Q: What is the career path for a Clinical Data Manager?
A: A Clinical Data Manager's career path typically begins with entry-level roles such as Clinical Data Coordinator or Data Associate, where they assist in data management, cleaning, and reporting. As they gain experience, they progress to mid-level roles like Clinical Data Manager or Senior Data Coordinator, overseeing data management processes, implementing data standards, and collaborating with cross-functional teams. Senior Clinical Data Managers or Lead Data Managers then assume leadership roles, overseeing large-scale data management projects, developing data management strategies, and mentoring junior staff, ultimately positioning themselves for senior leadership or specialized roles in data science, regulatory affairs, or clinical operations.
