The Company:
Our client is a leader in the design and management of complex, full service clinical trials (Phases I - IV) and patient disease registries for 11 out of 15 of the worlds leading biopharmaceutical and medical device companies. With operations in 26 countries worldwide, it is a recognized leader in clinical trial design for cutting-edge medical technologies in cardiology, oncology, infectious diseases, and gene and stem cell therapy.
Located in Suburban Philadelphia, the company stands on the threshold of dramatic, short and longer term growth in revenues and profitability and is seeking to attract the Delaware Valley's leading professionals in clinical research, project management and data management.
Position Description:
Reporting to the Director, Data Management, the Clinical Data Manager has overall responsibility for managing one or more Data Management projects. The Clinical Data Manager acts as the primary interface with the Sponsor, and represents Data Management on the protocol-specific project team.
Qualifications:
Bachelor's degree in a life science or mathematics related area (e.g. computer science) or registered nurse with 3 or more years of pharmaceutical data management experience preferred. Or, 4 or more years of pharmaceutical data management experience with increasing levels of responsibility without a degree. Incumbent must be familiar with corporate and departmental SOP's and ensure that he/she and his/her team members comply with them. Is knowledgeable or able to learn supervisory skills and assign clear responsibility for tasks, set objectives, monitor process and provide constructive relationships both internally and with sponsor personnel. Clinical Data Manager is able to consistently meet deadlines and complete tasks according to established levels of database structures (preferred if have experience with Oracle Clinical and/or Datafax); able to use SQL, SAS and/or other programming languages and be able to rapidly acquire and apply new technical skills.
Contact:
Position Overview
Reporting to the Director of Operations Technology, the Clinical Programmer has responsibility for providing programming support to the Global Data Services department including developing and maintaining standard data management reports, creating Sponsor and FDA datasets, and programming support for statistical projects.
Responsibilities
Design and implement automated, standardized data management reports that provide regular (e.g. daily, weekly, monthly) updates of the status of Global Data Services projects in a useable format suitable for both internal and Sponsor use
Create deliverable datasets from Oracle Clinical in format requested by the Sponsor and FDA (generally SAS transport)
Provide support for standardized and ad-hoc SQL queries
Assist in the development of standardized edit checks and the development of standardized data definitions leading up to implementation and support of CDISC
Assist in the development and implementation of standard operation procedures for clinical programming
Perform other duties which may be assigned or assumed as time and/or circumstances necessitate
Requirements
A bachelor's degree in Computer Science or related area (e.g. Engineering, Math) or a minimum of 3 years of related pharmaceutical experience
Proficient SAS programmer with documented success at both data manipulation and reporting
Skilled use of SQL tools for Oracle database query and report generation
Experienced with Solaris and Windows operating systems
In-depth understanding of complexities of clinical trial data
Detail oriented with excellent organizational and communication skills
Contact:
