Senior Clinical Data Manager - Contract

Senior Clinical Data Manager - MA - Contract

Position Summary:
Performs tasks related to the implementation of clinical data standards specific to database build and analysis and reporting, within a program or group of programs, for company outsourced studies.

Duties and Responsibilities:
* Represents SSI Operations as the primary compound lead for study start-up and data analysis activities within a program or group of programs
* Acts in a project manager capacity for deliverables supporting the reporting requirements under the Investigational New Drug (IND) application (e.g. IND, Annual Report, Clinical Study Report, and NDA)
* Represents SSI Operations on assigned Clinical Trial Working Groups (CTWGs) for study start up and data analysis activities
* Ambassador for clinical data standards governance process decisions, as applicable
* Acts as a key resource at the study team level on the rationale and principles in support of existing clinical data standards
* Ensures appropriate communication or escalation of study specific challenges and/or change requests proposed by the CTWG to the Standards Governance Lead
* Responsible for compilation of clinical data standards specifications and transmission to Company's Clinical Research Organization Partners
* Ensure CRO and CTWG adherence to clinical data standards and/or escalates to the Standards Governance Committee as required
* Monitors timelines to ensure SSI related deadlines are met
* Participates in the development of clinical data standards as applicable
* Participates in the review and piloting of new technologies as applicable
* Participates in process improvement and training initiatives as applicable
* Serves as a subject matter expert in processes relating to database build and analysis and reporting
* Develops a strong understanding of the drug development and clinical trial process and the roles, tasks, and activities for which SSI Operations assumes responsibility
* Participates in the development of Standard Operating Procedures (SOPs) and Work Practices (WPs) relating to SSI Operations
* Responsible for vendor oversight for SSI related activities
* May mentor junior SSI Operations Staff

Qualifications

Experience:
* BS/RN/RPH degree in health related field preferred, 5+years or MS degree with 3+years experience in Clinical Data Management (CDM) and/or clinical programming in the pharmaceutical/biotechnology industry; knowledge of Good Clinical Practice (GCP), regulatory and International Conference on Harmonization (ICH) guidelines as applicable
* Clinical experience in the oncology field preferred
* Experience working with cross-functional teams
* Electronic Data Capture (EDC) experience desirable or strong knowledge of SOPs, GCP standards and CDM systems

Other:
* Proven project management skills
* Ability to focus on multiple projects of different duration and complexity
* Exceptional organization effectiveness and detail orientation
* Excellent interpersonal and negotiation skills
* Excellent analytical skills and detail orientation
* Strong written and verbal communication skills with the ability to communicate technical concepts clearly and concisely with non-technical colleagues
* Knowledge of medical and statistical terminology preferred

To find out more about Real Staffing please visit www.realstaffing.com