Senior Clinical Data Manager
This position is responsible for managing, leading, and overseeing all clinical data management activities for clinical trials to meet corporate goals, budgets, and timelines. This includes but is not limited to vendor management, training and oversight for all aspects of CDM from study start-up through study close-out, final reporting, and archiving. The Sr. Clinical Data Manager will be responsible for supervising, managing, and leading the design, implementation and ongoing practices of clinical DM processes with internal study resources and/or vendors. This position reports to the Associate Director of Clinical Data Management.
- Serves as Clinical Data Manager by providing management of all data management activities. Directs data management activities according to quality standards, regulatory requirements and ensures adherence to project 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 meeting AnaptysBio’s requirements.
- Oversees interactions with vendors 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 metrics to the study team.
- Responsible for the oversight of data review, reconciliation and data cleaning activities for all studies.
- Assists in creation of timelines and ensuring all related CDM documentation is being created, maintained and archived.
- 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
- Evaluates 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 as needed regarding DM processes, workflow, and data standards that may have a direct impact on their work.
- Reviews and/or provide feedback on protocols, standard operating procedures (SOP), work instructions (WI) for data management department
- Performs other related duties as required and assigned.
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.
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. Requirements
Education & Experience
- Bachelor’s degree or an equivalent combination of education and work experience, 7+ 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.