Careers

Summary

This job description defines our requirements for an intermediate to senior level; however we accept applications for entry level as well (posted on 02-JAN-2013).

SCiAN's EDC-CDM Group is responsible for the data management activities associated with IND-stage phase I - III clinical trials of our North American and International Clients covering indications including oncology, CNS, infectious disease, immunotherapy, stem cell and gene therapies, etc. EDC solutions supported by SCiAN include both SCiAN's propriatery edc^pro platform and hosted 3rd-party systems.

The successful candidates will lead SCiAN's internal EDC-CDM project teams and will support and guide the Clinical Project Managers, CRAs, Study Coordinators and Specialists to ensure delivery of quality study data on time, on budget and to client specifications. He/She may also be called on to provide data management expertise for other project teams.

Key Responsibilities

On a project-by-project basis:

Project Management:

• Establishes the EDC-CDM sections of the project management plan per the  scope of work, study protocol, Sponsor requirements and SCiAN standards
• Ensures that all CDM activities defined in the project management plan are executed and completed per the project schedule and scope
• Trains and manages SCiAN's internal project team. The team is comprised of 2-5 members: a combination of clinical application programmers, data reviewers, medical coders; SAS / statistical programmers, medical reviewers, and drug safety specialists
• Responsible for maintaining the project management plan, tracking and issue log(s), and for reporting to management on study progress and the performance of the project team
• Manages day-to-day client interaction and status reporting
• Communicates effectively with clients to identify needs and solve any issues that arise.
• Ensures SCiAN's standards are upheld
• Reviews project deliverables prior to sending to the client.

Clinical Data Management:

• Liaises with Sponsor and designees on database design and functionality; compiles and maintains study database requirements and responsible for the development of configuration plan and data management plan
• Oversees design, implementation, testing and deployment of the study database and ensures completion of associated documentation
• Oversees development and maintenance of EDC user guide and other study database documents (e.g. FAQ)
• Conducts and manages end-user training (internal and external end-users)
• Responsible for monitoring database access, data integrity, usage, performance of edit checks, and recommends changes per these monitoring activities
• Oversees help desk and database change management activities
• Manages data transfers from 3rd parties and interim data exports
• Manages final database lock and audit activities including SAE reconciliation AE/CMED coding and others as defined in project scope
• Ensures the database documentation is consistent with study database, and manages the release of the database and database documentation as per SciAn SOPs.
• Oversees project closure activities (e.g. decommissioning of EDC system, release of eCRFs to sites, etc.).

Qualifications

Required:

• A degree in health or data/mathematical/statistical sciences
• Minimum of 3 years of experience in clinical data management projects in an EDC setting
• In-depth understanding of database structures and database programming  
• Solid knowledge of clinical trial processes, ICH GCP, and GCDMP (SCDM) and CDISC
• Able to alternately lead and work as part of a multi-disciplinary team
• Able to effectively communicate with internal and external stakeholders
• Strong oral and written communication skills
• Good presentation and training skills
• Self-motivated, with the ability to learn quickly and independently
• Demonstrated ability to problem solve
• Intermediate MS Office 2007 skills (Word, Excel, PowerPoint).

Desired:

• SCDM Certification
• PMP certification or demonstrated project management experience / education
• Experience with Domino/Lotus Notes
• Knowledge of software development life cycle
• Experience working in a regulated company.

Job Description

We are seeking qualified candidates for entry-level positions. Candidates should possess a strong desire to learn and grow with the company, while applying their training and excellent knowledge of statistical concepts to the biopharma industry.

Key Responsibilities
- Statistical programming (SAS)
- Statistical analysis
- Statistical report writing
- Data management

Other Duties

As assigned           

Qualifications
- B.Sc. or B.A. in Statistics/Mathematics
- Excellent programming skills (SAS preferred)
- Quantitative mind
- Organized/detail-oriented
- Applied statistics courses
- Knowledge of databases
- Excellent (English) verbal and written communication skills