Responsibilities include: Provide operational, strategic, and technical direction to data managers and technology SMEs while maintaining ultimate responsibility for all clinical data within the company. Accountable for all Clinical Data Management activities from study startup through study conduct and closeout delivering quality data snapshots, interim database locks and final database locks Design and deploy appropriate clinical data management operating models including full outsourcing, hybrid delivery and fully in-house Ensure clinical data management strategies that incorporate both current best practices and innovative approaches consistent with GCP and GCDMP Design and deploy sponsor oversight for outsourced studies including operating model, oversight planning and execution, vendor governance and interactions, risk management and documentation Define, advance and codify procedural framework (operating model, process definitions and associated SOPs/WIs, Clinical Data Management best/expected practices) for the department Serve on the Biometrics leadership team to provide guidance on direction and operations of the department Provide expert guidance to project teams and executive leadership Participate cross-functionally with key partners to advance products Contribute to and participate in the development and maintenance of a positive team-focused company culture

Education, Experience, and Skills:

Required:

Bachelor's degree with 12+ years of experience in the pharmaceutical or biotechnology industry in a Clinical Data Management leadership capacity Extensive experience with industry clinical data management delivery models and associated sponsor oversight (full outsourcing etc.) Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent Proficiency in Clinical Data Management related technology like EDC, eSource, e

COA, IRT

etc. Experience leading programs through submission and approval Deep understanding of GCP and GCDMP Solid understanding of eCRF data acquisition best practices

Preferred:

Ability to communicate with clarity and influence including explaining complex quantitative issues in simple terms Solid understanding of Regulatory (FDA/EMA/ICH) guidance with the ability to interpret and apply in real-time drug development setting Solid understanding of regulatory submission and approval process Collaborative negotiator with excellent judgment around compromising, standing firm, or finding a new way forward. Leadership acumen including emotional intelligence and business awareness. Ability to effectively collaborate and influence throughout multiple levels of the organization. Strategic and creative drug-development mindset/approach. Willingness to deviate from the status quo Ability to balance appropriate levels of structure/process with efficiency and simplicity Awareness of external industry landscape with respect to best practices and emerging topics Comp $300-330K based on experience