Managers of Clinical Programming provide leadership and high-level expertise to the Clinical Programming group. They are responsible for coordinating all activities and personnel within clinical programming, for mentoring clinical programmers across multiple project teams, along with performing resource allocation and timeline coordination. They oversee project teams that contribute to data tabulations, statistical analyses, clinical development, and regulatory submissions. They supply expert advice on complex problems where analysis of situations or data requires an evaluation of intangible variables. They develop solutions to abstract problems within existing systems and processes where feasible, and utilize ingenuity and creativity to develop additional new solutions. Managers of Clinical Programming lead initiatives to develop standards, systems and procedures. The work requires an understanding of the theories and methodologies behind the conversion, tabulation, analysis, reporting, and integration of clinical data. It requires the ability to apply knowledge of the SAS® statistical programming application and other software languages and tools along with knowledge of industry-accepted standards, including CDISC SDTM and ADaM. Managers of Clinical Programming ensure that staff members fulfill responsibilities in accordance with PRA policies, procedures, SOPs, ICH?GCP guidelines, local regulatory authority regulations, and client requirements.
* Oversee clinical programming activities for Phase I-IV studies, integrated databases and analyses, safety reviews and ad-hoc analyses.
* Develop and manage programming services; providing programming resources and project management of clinical programming activities and deliverables.
* Establish and maintain strategic client relationships including support of corporate business development and marketing activities at client presentations and professional seminars.
* Supports the leadership of Data and Programming Services on short-term and long-term strategies to improve efficiencies in Clinical Programming, through collaboration with senior management.
* Use all information available and proactively seek required information to predict resource requirements and recruitment needs.
* Maintain awareness of and disseminate new developments in programming techniques and standards which may be applied to the management and reporting of clinical trial data.
* Provide input into budgetary requirements; perform ongoing financial review of assigned projects; promptly identify, communicate, and manage both risks and issues; and support the project team to ensure all out-of-scope tasks are identified, tracked and included in change order forms.
* Maintain utilization of all clinical programming staff within department goals.
* Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
* Ensure quality work within the group and department through ongoing review and improvement of processes and procedures to ensure high quality deliverables to clients and internal customers.
* Ensure staff are mentored and trained appropriately; foster career development and self-improvement of staff; develop future managers.
* Recruit and retain high quality employees.
* Identify departmental initiatives to provide process and technical efficiencies for clinical programming, ensuring global clinical programming awareness and resolution.
* Promote and positively raise the profile of PRA and its services externally through active participation with external bodies and membership organizations, supporting business development activities and recruitment.
* Other tasks as assigned.
PRA is an Equal Employment Opportunity / Affirmative Action Employer
* Undergraduate degree or its international equivalent from an accredited institution.
* Advanced degree (e.g., M.S., M.B.A., Pharm.D.) Proven skills with industry standards is preferred.
* 5 years of experience performing Clinical Programming tasks including creating tabulation and analysis datasets and TFLs etc.
* 2 years of experience of working in a multinational environment.
* Demonstrated ability in leading development initiatives to successful conclusion.
* Previous line management experience.
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