Program Manager - Clinical Database Services
As an individual contributor,
Operates as a Subject Matter Experts (SME) of clinical database and Electronic Data Capture activities including the creation of clinical databases and data transfer files. Needs to have strong Programming (C#, Java, Python), and database programming (Oracle SQL, PL/SQL, Postgres, SQL Server) skills. Need to have extensive knowledge about the EDC such as Inform, Veeva, Rave and Data Transformation tools such as DMW, CDB. Ability to increase functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts.
Coordinates clinical database activities for clinical programs including the review of eCRFs, edit check specifications, database development and may be asked to perform these activities if warranted. Ensures adherence to clinical database standards, SOPs, and Process Guidelines. Plans appropriately to ensure adherence to timelines for all clinical database services deliverables and escalate risks to management. Interface with members of study teams to integrate study team requirements into all deliverables. Interface with CDS manager/supervisor to assure consistency of technical and process strategies. Aligns others around a positive direction. Develops challenging but achievable objectives that clearly support stated organizational goals. Interacts and communicates clinical database processes and requirements to external vendors.
Leads and participates in extra activities including, but not limited to, improvement task forces, automations, testing of new systems and helps coordinate CDS technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing clinical database support to other departments. When necessary, may perform development activities such as database development or Peer Review.
Provides oversight to Clinical Database Developers. Participates in the recruitment process, mentoring and training of new hires and ongoing technical development of Clinical Database Developers. Provides input into the performance appraisals of Clinical Database Developers to management. Ensures the adherence to standards in the development, documentation, and maintenance of data dictionaries.
Bachelor’s degree in computer science or equivalent educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
Minimum of 5 years pharmaceutical experience within clinical research
Minimum of 10 years of Technical/Programming experience.
2 years of project management experience.
Demonstrates a high level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data, clinical database development tools, standards, and the development process in support of clinical research.
Working knowledge of Electronic Data Capture Systems or Data Management Systems
Solid knowledge of MS Windows/Office software and exposure to web-based applications.
Ability to establish and maintain good working relationships with different functional areas.
Strong sense of urgency and customer focus.
Possesses excellent communication skills and interacts effectively with Study Team.
Strong organizational, time management, and multi-project coordination skills
Broad knowledge of Clinical Development and Regulatory Affairs requirements
Ability to multi-task, work independently and good communication skills
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
Conducts management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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Expected salary range:$130,960.00 - $206,200.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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