- Oversee data management activities at vendor from CRF/database development through database lock
- Collaborate with study team during protocol development with the duration of the program in mind to ensure the operational team is poised for successful data
- Accountable for database integrity and accuracy
- Ensure the completeness, accuracy, and consistency of data so that they meet the standards of quality expected for reporting to regulatory bodies.
- Assists in identifying and resolving data management issues on assigned studies
- Responsible for ensuring data management timelines are met within assigned studies
- May assist Biostatistics in development/review of Statistical Analysis Plans
- Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable
- Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorization Application (MAA), including integrated databases
- Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities
- Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality
- Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies
- Assists with the development of standards and process documentation, including Standard Operating Procedures
- Assures compliance with industry quality standards, guidelines and procedures
- Hire, train, coach and mentor all team members under him/her; set objectives and conduct performance reviews to foster growth of staff
- Responsible for department budget process and management
- Lead all DM activities including data collection forms (CRFs, diaries and CRF completion guidelines), clinical databases, study related data management documents, SOPs, etc.
- Adhere to FDA regulations (21 CFR Part 11, GCP), ICH guidelines and internal SOPs
- Interface with CRAs and other Clinical Operations team members to ensure the quality of data collection
- Bachelor's degree in Life Sciences, Mathematics or related field required
- 8-10 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry
- Previous experience in clinical data management, including database set-up, data validation and consistency checks, initiation, and closure of trial databases, CRF design, query resolution, review and reporting of laboratory and safety data, coding, and SAE reconciliation or equivalent
- Knowledge of medical terminology
- Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency with data management systems and supporting statistical programs (e.g., SAS)
- Knowledge of database design and database concepts
- Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals
- Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
- Excellent written and oral communication skills, including experience with production of requirements documents, technical specifications, and other components of a clinical study database development process
- Highly detail-oriented
- Solid problem-solving and decision-making skills
- Hybrid work schedule out of our La Jolla office, 2-3 days a week or remote work
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
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Director, Data Management - San Diego, United States - Longboard Pharmaceuticals, Inc.
Description
Job Description
Job DescriptionJob Title: Director, Data ManagementReporting To: EVP, Head of Operations
Department: R&D: Clinical Operations
People Manager: Yes
FLSA Status: Exempt
Location: Remote or Hybrid out of San Diego (2-3 days a week in office)
Position Summary
We are seeking a highly experienced Director of Data Management to lead our data management team in the planning, execution, and delivery of high-quality data for our research programs. The Director of Data Management will have a strong background in clinical data management and leadership experience. Reporting to the EVP, Head of Operations, this role will serve as a member of the clinical operations leadership team.
Responsibilities include but may not be limited to:
Minimum Requirements
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $200, $220, The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
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Director, Data Management professionals in La Jolla
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Linh Voong
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Rishi Gondkar
Grad CS student @ UCSD |MPL, Mitacs '21, GSoC '20