Manager, Clinical Data Management - Alphatec Spine

ATEC Spine is Revolutionizing Spine Surgery, a mission that requires continual investigation of clinical requirements and validation of novel solutions. An ATEC Manager of Clinical Data Management supports the company’s Clinical Research initiatives by using his/her CDM skills and experience to influence all stages of sponsored and site-initiated clinical studies and data collection efforts in partnership with our clinical practice partners. Specifically, the position identifies and implements best practices to ensure that study data are complete, reliable, and processed correctly. Tactically that includes contributing to the appropriate design of study protocols, study-specific case report forms (CRFs); developing appropriate and effective database structures; ensuring quality collection and compilation of study data, such as through query identification, discrepancy management and database locking; and managing interim and final data analysis and output of descriptive, inferential, and predictive findings from studies of various designs. The role assumes a level of autonomy consistent with commensurate experience, supervisory of data analytical personnel and/or processes, and collaboration with other members of the Scientific Affairs department as well as product marketing and development.

Essential Duties and Responsibilities

• Demonstrates subject matter expertise in all aspects of the CDM discipline, including the team’s strategy, capabilities, systems, and deliverables
• Contributes CDM expertise to the development of study designs (e.g., sample size estimation, hypothesis testing plans, data collection strategies), requiring an understanding of the objectives, methodologies, and systems used for clinical research
• Assists in the development of protocol-specific cases report forms (CRFs) and guidelines for accurate CRF completion
• Develops protocol-specific data management plans
• Designs and manages database structure according to study protocol/objectives and data curation as necessary for facilitation and optimization of data analysis, and compliant with ATEC’s data privacy and security standards and policies
• Leads the implementation and execution of processes for quality data collection, curation, and deviation and query management to identify errors and inconsistencies in clinical study data and ensure their resolution
• Oversees the locking, cleaning, and transforming of the data for interim analyses that inform the ongoing data collection effort
• Manages the data analysis effort, including interim and final analytical reports; employs own and/or team expertise and experience with descriptive statistics and inferential statistics, as well as advanced data visualization techniques to create data dashboards and reports to be used by varying levels of internal and external stakeholders such as clinical research management team and study collaborators
• Collaborates with other research personnel to generate factual and accurate output from study data, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral
• Proposes, drafts, and maintains relevant standard operating procedures (SOPs) and other policies and procedures relevant to CDM and in accordance with regulatory requirements
• Participates in the identification and selection of external data management vendors as applicable
• Manages the execution of projects to budget and time expectations
• Builds and leads a high-performing CDM team including full time employees, contractors, and third-party vendors, as applicable
• Collaborates closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the clinical activities within the team
• Collaborates with research and development engineers as well as product marketing to understand the products under study, the objectives of the research, and to communicate study findings
• Accesses ongoing training and professional development to maintain familiarity with current industry and academic research to apply the latest and most useful CDM strategies
• Performs other duties as required

Supervisory Responsibilities

• Hires and manages clinical data analysts, and/or other data management personnel
• Fosters continued development of team members, including technical and clinical expertise

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Superior problem-solving skills with a solid understanding of, and firsthand experience in and/or working with, clinical research operations and the principles and processes of scientific data collection and management methods
• Experience with clinical data lifecycle from database set-up and maintenance to database lock and archiving
• Strong experience in design and validating eDC databases and performing data review
• Strong analytical skills and advanced proficiency in database platform and analytical tools such as Excel, SQL, Python, R, SAS, Tableau, Power BI
• Knowledge of GCP, ICH and other regional regulations and compliance
• Strong project management skills and experience
• Superior organization skills, attention to detail, and the ability to keep detailed, accurate records
• Demonstrated ability to work collaboratively with multifunctional internal and external teams
• Excellent creative thinking skills
• Excellent oral and written communication skills
• Ability to organize and prioritize workflow to meet established timeframes, while working in a fast-paced and goal-oriented environment
• Ability to work within a cross-functional team and matrix management structure
• Ability to exercise independent judgment consistent with department guidelines
• Ability to learn and maintain knowledge of procedures, products, and activities of assigned area
• Proficiency with common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required

Education and Experience

• Minimum 4 year/Bachelors Degree in a field of applied research such as Data Science, Machine Learning, Mathematics, Statistics, Business Analytics, or Public Health
• 5+ years, with at least 2 years managing people - Direct experience in clinical research data analytics preferably working for a Sponsor, preferably in medical device (spine industry a plus)

Certificates, Licenses, Registrations

CHDA, CCDM, CCRP, CCRA preferred

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $90,000 to $110,000 Full-Time Annual Salary