Senior Manager Clinical Data Management

1) Support the development of strategic plans aligned with business goals.

2) Translate strategies into operational plans and guide others in linking their activities to CDM's strategic goals.

3) Accountable for the acquisition, management and development of human resources.

4) Prepare project budgets and manage financial performance.

5) Develop resourcing plans and manage the allocation of resources.

6) Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data.

7) Develop and manage partnerships with External Service Providers (ESPs) (e.g. CROs, Central Labs and Recruitment Firms) in order to support business goals and further the mission of CDM.

* In depth knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
*

Excellent analytical, decision-making, organizational, managerial, interpersonal and communication skills
*

Ability to interpret and apply regulatory requirements
* Experience in the planning, conduct and documentation of qualification and compliance assessments
* Demonstrated ability to effectively develop and manage relationships with ESPs
* Technical understanding of clinical research technologies and software development methodologies
* Knowledge of systems integration and data interchange standards
* Proficient in the use of one or more of the leading Clinical Database Management Systems or clinical programming environments
* Experience leading continuous process improvement initiatives with a proven track record of success as measured by return on investment

Current with industry developments, trends and opportunities

* Bachelor's degree required, Master's degree in a related field or MBA preferred.
* 5+ 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