Large CRO Seeking Senior Project Manager / Associate Director
Senior Project Manager / Associate Director of Clinical
Therapeutic Area: strong TA experience within Oncology/Immunology and Internal medicine/Cardiovascular and Metabolic/CNS/Allergy, Respiratory, Infectious Diseases/Vaccines.
RESPONSIBILITIES (to include but not limited to)
- Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for medium, multiple service, multiple country and/or region studies. Understand project strategy and translate the agreed upon approach.
- Develops integrated study management plans with the core project team.
- Accountable for the execution of clinical studies while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
- Build the cross-functional project team and/or sub-team(s) and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
- Ensure the financial success of project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
- Provide input to line managers of their project team members¡¦ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad protocol knowledge; therapeutic knowledge desired
- Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Project management practices and terminology
- Strong understanding of, and experience managing, contractual obligations and implications
- Demonstrate strong understanding of project financials and experience managing project P&L
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
- Excellent communication and presentation skills, including good command of English language
- Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project and taking account of a wide range of issues across, and related to, the project
- Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or related field and 7 years clinical research experience including 4 years project management experience; or equivalent combination of education, training and experience
For further information about this role and to be considered as an n applicant please get in touch with Taylor Ahearne at firstname.lastname@example.org/+1 646 415 8221
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