Position Summary 

The Sr. Manager, Clinical Data Management will be responsible for supporting data management activities in phase 1 – 4 clinical trials. The incumbent will oversee outsourced studies ensuring appropriate interpretation and translation of the study protocol into validated data collection applications, tools, and systems (EDC, eCOA, IWRS), cleaning and validation of the data, and delivery of fit for use data for analyses. The individual must have working knowledge of regulatory guidelines, project management principles, risk assessment/management and problem solving skills. Communication, both written and verbal are critical success factors in managing the expectations and delivery of/to the cross functional study team, the CROs executing the study, leadership, and management. This position reports to the Director of Clinical Data Management.  

Essential Functions

• Serves as Data Management project manager by orchestrating all data management activities according to quality standards, regulatory requirements and ensures adherence to project timelines and budget from study start up through archival.
• Oversees the development of CRFs and CCGs with other functional area representatives and ensure all applicable data management databases are developed, validated, and meet AnaptysBio’s requirements. 
• Oversees interactions/ deliverables with 3rd party vendors and CROs on collection, transfer, reconciliation of study specific data. Ensure proper execution of data management activities, communicating data trends, observations and ensuring the CRO is providing relevant and actionable metrics to the study team. 
• Responsible for the oversight of data review, reconciliation, and data cleaning activities for all assigned studies.
• Accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standard
• Monitors Data Management outsourced activities to ensure efficiency and regulatory compliance. Provides study teams with feedback on selecting Data Management vendors during selection process.
• Cultivates effective and productive working relationships with colleagues, junior staff, vendors, and management as well as solve problems and escalate issues with proposed solutions to Senior Management as needed.
• Educates clinical team members in matters of DM processes, workflow, and data standards that may have a direct impact on study execution.
• Reviews and/or provide input on protocols, standard operating procedures (SOP), work instructions (WI) for data management department 
• Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.
• Performs other related duties as required and assigned. 

Education & Experience: 

• Bachelor’s degree or an equivalent combination of education and work experience, 6+ years of relevant CDM experience in biotech and/or pharmaceutical/drug development
• Vendor management and global experience is highly preferred.
• Experience to work effectively in a smaller company environment with experience in a hands-on early development role is a plus.
• Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
• Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.

Personal Competencies: 

• Effective communication and interpersonal skills.
• Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well.
• Self-motivated, independent, and results-oriented.
• Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines.
• Highly attentive to details.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate. May be required to travel by plane or car

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.