Project Leader/Senior Project Leader Job in Raleigh/Durham-Rtp 02451, North Carolina US

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

The primary role of the Project Leader is to lead and manage domestic or international projects. May be part of a global project management team. Requires some interaction/supervision by Line Manager or Senior Project Leader or Director. Project Leaders may mentor junior staff and Functional Leads for specific projects. Project Leaders participate in proposal development teams, giving input to particular indication and operational structure for the proposal. Project Leaders are responsible to represent Project Management at marketing/new business meetings.
General areas of responsibility include: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between PAREXEL project team, Sponsor, contract and financial management.

The primary role of the Senior Project Leader is to lead and manage domestic or international projects and may oversee a series of small programs on a particular compound. May be part of a global project management team. Requires minimal interaction/supervision by Line Manager or Senior Project Leader or Director. Senior Project Leaders may mentor Associate Project Leaders and Functional Leads for specific projects. Project Leaders participate in proposal development teams, giving input to particular indication and operational structure for the proposal. Project Leaders are responsible to represent Project Management at marketing/new business meetings. The Senior Project Leader will support Leadership by developing ways to align people¿s contribution to business goals and strategic thinking and developing a mentoring and learning behavior for Project Leaders.
General areas of responsibility include: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between PAREXEL project team, Sponsor, contract and financial management.

Proven relevant experience in healthcare, clinical research, project management or contract research organization.
Peri-approval study phase experience necessary with large scale post-marketing, EAP and/or remote monitoring trials. Experience working with research-naive sites and in providing creative solutions to Sponsor organizations in the post-marketing area.

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