The Senior Clinical Programmer Analyst will lead the data management team in building protocol specific EDC systems, creating forms, screens, edit checks, dynamic forms, and interacting with external data vendors to support the import and / or reconciliation of external data. Provides training in the use of EDC, maintains up to date knowledge of new releases and validation requirements. Creates ad-hoc, project- specific, or system reports and works cross-functionally in the development, training, and maintenance of the EDC systems.
DUTIES AND RESPONSIBILITIES:
- Complete assigned work utilizing IBM Clinical Development (Merge), nowEDC, or other EDC systems according to MedSource SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices
- Leads the building of project specific EDC systems; program integrated and associated components as assigned (IWRS, Pharmacy, coding, etc.)
- Provide support and trouble-shooting of EDC, and act as the study team liaison.
- With assistance meet with data manager on assigned projects to discuss technical strategies, contractual obligations and timelines. Escalate resource needs as appropriate.
- Provide consultation in the area of database design and development with data managers.
- Prioritize personal workload to meet specified completion dates and perform work without direction.
- Conduct Peer Review/ Quality Control of study design for assigned projects.
- Review and approve derivation and edit checks requested by the project teams. Discuss alternative programming for procedures, if appropriate.
- Program, test, and maintain derivation and edit check procedures in the EDC environments.
- For EDC systems.
- Develop, implement and manage the importing and management of external data
- Manage projects within the scope of assigned budgets
- Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
- Assist in the development and implementation of data management software tools, EDC systems, or other proprietary software, including proactive prevention strategies
- Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
- Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.
- Participate in the evaluation and validation of new or updates to software
- Provide expert technical guidance to project teams, external clients and internal clients within a global setting.
The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- BA/BS (life science, computer science, programming, or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., computer science, medical or laboratory technology)
- 8-10 years of relevant work experience to include data management and database programming activities with at least 4 years of EDC experience preferably in IBM Clinical Development (Merge), or equivalent experience in nowEDC, Medidata RAVE, Clinical Studio, or other EDC systems
- SAS programming skills
- Broad knowledge of drug development process and ICH / GCP
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent problem-solving skills, a proactive approach, self-motivation, and the ability to make sound decisions
- Demonstrated skill in leading teams, by example and mentoring staff
- Excellent oral and written communication and presentation skills
- Knowledge of clinical trial process and data management, CRF Design, SAS programming and systems applications to support operations
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
- Demonstrated ability to work in a team environment and in handling multiple competing priorities
- Excellent interpersonal and organizational skills with strong attention to detail.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of clinical research
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
- Up to 5% of travel required