Chief Clinical Data Manager

SDC is a team of diverse professionals providing outstanding Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005, our mission has been to collaborate with sponsors, supplying high-quality and experienced team members to create impactful medicines that save lives and cure diseases as efficiently as possible. Our worldwide team serves as a trusted partner to our clients, treating their needs as our own and delivering excellent results. Our approach as a specialty CRO is defined by scalable service offerings, a focus on specific service areas, efficient project timelines, cutting edge technology solutions, and a proven track record of success and experience. This role will support the Manager of Data Management in overseeing and executing Data Management operations. Responsibilities include supervising all data management operational activities for both clinical and non-clinical research studies, from study construction through to study closure. This role will also mentor and train Clinical Data Management staff. ***Candidates must reside in Arizona or along the east coastal line in the US*** ***Recruitment agencies, please refrain from submitting unsolicited referrals for this or any other vacancy. We have established agency partnerships and will not pay any fees connected with unsolicited referrals.*** Primary Responsibilities: - Efficiently plan and execute multiple Data Management projects at once, providing updates to senior stakeholders as requested by management. - Act as a subject matter expert. - Participate in Business Development presentations and bid development. - Assign tasks and responsibilities within Data Management to optimise team capacity, deliver timely and accurate results, and support business needs. - Mentor and guide data management staff in daily operational activities. - Communicate with cross-functional groups and stakeholders throughout the project lifecycle. - Manage sponsor relationships and triage issues as appropriate. - Participate in and/or contribute to sponsor and/or regulatory audits/inspections. - Maintain the quality control of clinical data, project deliverables, and closeouts. - Adhere to all aspects of SDC’s quality system and data integrity requirements. - Perform other duties as assigned. Requirements: - Exceptional knowledge of clinical trials and the data management role. - Excellent organisational and project management skills. - Expert understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations. - Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products. - Ability to work independently and in teams. - Strong project management abilities including analytical evaluation, flexible team management, negotiation, and resource management skills. - Excellent organizational and time management skills, with the ability to multi-task. - Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). - Strong interpersonal communication and presentation skills. - Ability to effectively collaborate across cross-functional teams. Education and Experience: - Master’s degree (preferably in engineering, applied or life science) and at least five (5) years of experience in clinical data management. - Bachelor’s degree (preferably in engineering, applied or life science) with at least seven (7) years of experience in clinical data management. - Current Certified Clinical Data Manager (CCDM) status and at least seven (7) years of experience in clinical data management. Benefits: Here's what you can expect from us: - Commitment to employee development with opportunities for career advancement and a flexible work schedule. - Recognition program tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. - A culture club with fun and engaging activities. - Encouragement of diverse perspectives to foster growth in this ever-evolving industry. - A proven track record of successfully executing client clinical programs since 2005. - Health Care Plan (Medical, Dental & Vision) - Retirement Plan (401k), Life Insurance (Basic, Voluntary & AD&D) - Paid Time Off (Vacation, Sick & Public Holidays) - Maternity and Paternity Family Leave - Short-Term & Long-Term Disability - Training & Development - Work From Home opportunities - Profit-based incentives