Associate Director, Clinical Systems Implementation

Job Description

Join our team at our company, a premier research-intensive biopharmaceutical company. We are seeking an Associate Director, Clinical Systems Implementation to manage activities related to the successful implementation and use of multiple applications. This role is an opportunity to work at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. 

Responsibilities 

• Manage activities related to the successful implementation and use of multiple applications. 

• Represent Global Clinical Trial Operations (GCTO) (business) in application related decisions that may or may not have a global impact. 

• Ensure compliance to Company, local laws and agency regulations and related guidance around technology. 

• Apply data stewardship and data governance principles in the management of the application. 

• Collect, assign, track, and prioritize requests from users requiring modifications to existing systems.

• Approve change requests for upgrades/bug fixes/data changes and coordinate release planning and assessment for the business in collaboration with IT. 

• Ensure business needs and criticality of functionality are correctly documented in SDLC documentation. 

• Review and approve appropriate validation documentation. 

• Partner with the IT Product Manager & Business Analyst to enable new system enhancements. 

• Provide subject matter expertise to business users of the application and system owners of the integrated applications. 

• Ensure business has appropriate training materials and process documentation to support the use of the system. 

• Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner. 

• Contribute to the ongoing development of global standardized procedures for the use and maintenance of the application across functional groups and countries. 

• Monitor support metrics and performance of the system on routine basis to assess needs for improvements. 

• Facilitate trainings to ensure users are appropriately trained in the use of the system. 

• Collaborate with IT to ensure internal Service Level Agreement (SLA) is created for the application, reviewed and updated once a year. 

• Manage UAT related activities such as assessing UAT needs, developing and communicating high-level UAT plans. 

• Responsible for completion of risk and privacy assessments and ensure adherence to risk and privacy policies. 

• Act as primary business contact for assigned systems during audits and inspections and collaborate with IT and process owners to respond to all audit and inspection related requests in a timely manner. 

Qualifications 

Education Requirement:

• BS degree with 12 years of professional experience.

Or

• MS/MBA/JD degree with 10 years of professional experience.

Or

• PhD with 5 years of professional experience. 

Experience Required:

• At least five years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support. 

• Basic understanding of System testing & providing training to user communities. 

• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required. 

• Basic knowledge of Site Monitoring, Study Start up, Data Management, Pharmacovigilance, Essential Document Management, and Investigator/ Study Coordinator roles/ responsibilities. 

• Experience with critical clinical systems such as CTMS, eTMF, Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools. 

Preferred 

• Five years of experience in clinical research/clinical development. 

• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. 

• Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs. 

• Skilled in MS Access, MS Excel, SQL or other database/query tools a plus. 

• Recognized as “team player”. 

• Possess good project management skills. 

• Committed to continuous improvement. 

• Analytical ability, good judgment, ability to multi-task. 

• Strong verbal & written communication skills. 

• Ability to p