Associate Director, Clinical Data Management

About the Role >>> Associate Director of Clinical Data Management

As the Associate Director of Clinical Data Management reporting to the Director of Clinical Data Management, you will be responsible for all data processes related to assigned studies, overseeing data collection workflows across the EDC database and non-EDC data sources. You will ensure the quality and integrity of all clinical data via CRF and edit specifications, Data Management plans, data systems validation and UAT, listing generations, as well as review of clinical data for completeness, accuracy, and compliance.

This role is based out of our San Francisco, CA or Cambridge, MA office and will require 10% travel.

Your work will primarily encompass:

• Lead study start-up activities (CRF design, UAT, edit checks review, etc.) and ongoing data management activities (e.g. reconciliations, data cleaning initiatives)

• Day-to-day management of vendors involved in data production and manipulation, to ensure quality of deliverables and that set timelines are met

• Develop and review study plans and protocols to ensure that data collection and CRF design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines)

• Develop and review specifications for database build and validation, edit checks, external system integration, or for other systems and processes related to data while enabling near-real time data access for Olema clinical trials

• Ensure data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans

• Gather input from stakeholders and design data flow across EDC and non-EDC data sources and across vendors

• Oversee SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical database

• Provide subject matter expertise to study team members during all phases of the project life cycle, electronic data capture, external data standardization, and prior, during, and after internal and external audits and inspections

• Manage development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements

• Integrate external data collection through data transfer agreements (including but not limited to ePRO, laboratory data, IRT, etc.)

And will also include:

• Participate in internal team meetings and provide data management updates on assigned studies

• Interface with Clinical, Biostatistics, Clinical Science and Project Management to troubleshoot data-related problems

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• BSc. / B.A. degree or advanced degree in a relevant discipline (science, biology, mathematics or computer science) required

• CCDM certification preferred

• Practical knowledge of MedDRA, WHODrug and/or another controlled Thesaurus

• Deep expertise in Excel and Microsoft Office tools

• Relational database understanding and SQL knowledge

Experience:

• 10+ years of experience in data management in clinical trial industry (pharma or biotech)

• Prior phase 3 global study lead experience in oncology is required

• In-depth understanding of clinical and Data Management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR and functional knowledge of CDISC/SDTM/SDTMIG standards

• Extensive experience managing Data Management CROs

• Deep experience in reviewing complex and large clinical datasets

• Hands-on deep experience working with EDC systems (e.g. Rave, etc.), IRT systems, ePRO systems, and data visualization tools

• Practical experience building studies using CDISC/CDASH standard

• Experience with management of data flow and curation of biomarker data preferred

• Experience with a programming language preferred

• Experience managing data management professionals is preferred

Attributes:

• Excellent verbal and written communication skills, coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision

• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

• A commitment to excellence

• Be collegial, hard-working, confident, a self-starter and results-driven

• Be a fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others

• A demonstrated ability to make decisions in situations where there is incomplete or ambiguous information and where there is a high degree of professional judgment required

• Have impeccable professional ethics, integrity and judgment

The base pay range for this position is expected to be $180,000 - $190,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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