Description
Overview:- Manage the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables.
- Lead the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines.
- Support the training and development of certain CDM study personnel (e.g. Clinical Data Analyst I & II's) through formal training and guided mentorship.
- Support the preparation of project budgets and financial reporting.
- Assist in the development of study resourcing plans and direct the activities of certain CDM study personnel.
- Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data.
- Represent CDM in study team meetings and facilitate cross-functional activities
- Partner and openly communicate with the study team to proactively address operational issues and clinical data questions.
- Manage partnerships with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM.
Qualifications
- Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills
- In depth knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
- Ability to interpret and apply regulatory requirements
- Knowledgeable concerning all aspects of qualification and compliance assessments
- Demonstrated ability to effectively develop and manage relationships with ESPs
- Technical understanding of clinical research technologies and data validation methodologies
- Knowledge of systems integration and data interchange standards
- Proficient in the use of one or more of the leading Clinical Database Management Systems
- Experience supporting continuous process improvement initiatives with a proven track record of success as measured by return on investment
- Current with industry developments, trends and opportunities
Education and/or Experience: Minimum: BA/BS + 4 years experience or equivalent.
Preferred: Master's degree in a related field. 3+ years of CDM experience in the Pharmaceutical, Device or Biotech industries (Sponsor, CRO or combination) in roles of increasing responsibility.
To find out more about Real please visit www.realstaffing.com