Job description
General Summary: The Director will oversee clinical programming teams covering offices within a geographical region. They will provide leadership, strategic direction, and high-level expertise to the Clinical Programming group, acting as an escalation point whilst coordinating all activities and personnel within clinical programming. Directors identify and lead initiatives to develop standards, systems and procedures, utilizing ingenuity and creativity to develop solutions to problems. Effective customer management is an essential part of the role. 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. Directors ensure that staff fulfill their responsibilities in accordance with PRA policies, procedures, SOPs, ICH‐GCP guidelines, local regulatory authority regulations, and client requirements.
Accountabilities:
1. Oversee clinical programming activities for Phase I-IV studies, integrated databases and analyses, safety reviews and ad-hoc analyses across all Clinical programming teams in a defined region.
2. Develop and manage programming services, providing programming resources and project management of clinical programming activities and deliverables.
3. Identify, establish and maintain strategic client relationships including support of corporate business development and marketing activities at client presentations and professional seminars.
4. Represent clinical programming for significant business development activities including, but not limited to; RFP/RFI generation, bid defense preparation and meetings, preferred partner and strategic project initiatives.
5. Identify, lead and sponsor departmental initiatives to provide process and technical efficiencies for clinical programming, ensuring global clinical programming awareness and resolution.
6. Identify, Lead and sponsor clinical programming change management initiatives, ensuring that the expectations of PRA and client personnel are managed and communicated effectively.
7. Predict project pipeline, resource requirements and recruitment needs/strategies.
8. Dynamically maintain utilization of all required clinical programming staff, ensuring that permanent, cross-site, third party, and contractual resource utilization is contained within department goals. Ensure productivity metrics are in place and tracked.
9. Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
10. 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.
11. Ensure staff are mentored and trained appropriately; foster career development and self-improvement of staff; develop future managers. Recruit and retain high quality employees.
12. 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.
13. Act as the clinical programming representative for a specific client and/or PRA partnerships.
14. Provide budgetary requirements for strategies; perform ongoing financial review; promptly identify, communicate, and manage both risks and issues; and ensure all out-of-scope tasks are identified, tracked and addressed.
15. Other tasks as assigned.
PRA is an Equal Employment Opportunity / Affirmative Action Employer
Desired Skills and Experience
MINIMUM QUALIFICATIONS
· Undergraduate degree or its international equivalent from an accredited institution required, Advanced degree preferred.
· 10 years of experience managing programming teams within the pharmaceutical industry.
· 2 years of experience of working in a multinational environment.
· Previous line management experience.
· Proven track record in finding solutions to complex technical Clinical Systems.
· Cross functional strategic and leadership experience to develop and implement solutions.
· Demonstrated ability in leading development initiatives to successful conclusion.
Apply Now - Resume or CV with Job Post Title
Email: jobs@aarenconsultants.in
Posts
