Contract R&D Project Planner II in Irvine, CA at Apex Life Sciences

Date Posted: 8/10/2018

Job Snapshot

Job Description


Specialist II

R&D Project Planner is responsible for supporting Clinical Trial by strategically developing and maintaining clinical study timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. This person will work in a team orientated environment and is empowered to drive clinical study activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements. 

PRIMARY JOB RESPONSIBILITIES:

1. Develop and maintain high quality, realistic, cross functional clinical trial plans from study concept through completed clinical study reports. Specialist II, R&D Project Planner will develop the study timeline when the synopsis/draft protocol is available.

2. Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.

3. Develop and maintain NA/ROW clinical study timelines to meet all Allergan and CRO deliverables.

4. Partner with the Clinical Development lead, Global Operations department and the study team to ensure timely delivery of all clinical study milestones. Specialist II, R&D Project Planner will be expected to identify gaps and risks in the study plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.

5. Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.

6. Responsible for arranging and leading discussions on the clinical study plans.

7. Present clear clinical study reports to stakeholders within Allergan.

8. Partner with study team leaders to tactically drive critical path elements within the study.

9. Work collaboratively with Feasibility Analytics for Clinical Trials, Global Site Start Up Operations and Global Site Management Operations to advantageously reduce timelines for study start up activities.

10. Operate within the Allergan Governance Board model for communication and accountability. III. ADDITIONAL JOB RESPONSIBILITIES:

11. Provide continuous improvement on individual clinical study plans and standard Planisware templates.

12. Assist in developing the department portfolio based schedules and resource planning methodologies.

13. Identify state of the art planning tools to minimize deviations from established timelines.

 POSITION QUALIFICATIONS:

* Life science and/or business degree with at least 5-10 years of experience. MS degree and PMP certification desirable.

* Strong knowledge of and experience with clinical study processes.

* At least 3-5 years of Project Management experience required.

* Excellent written, communication and organizational skills.

* Strong MS Project and/or Planisware experience required.

* Ability to multi-task and perform under demanding and aggressive timelines while remaining focused on the study goals.

* Proven ability to interact with different functional groups.

To apply to the position please send resume or contact, Vickie Dagit, vdagit@apexlifesciences.com, 919-334-0178

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.