18 days old

Temporary Project Manager

Exelixis, Inc.
Alameda, CA 94501
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  • Job Code
    2438
Position Description

The Project Manager embedded within the Biostatistics, Clinical Data Management and SAS Programming (BCDM) department will define, document, track and hold the department and our external vendors accountable to highly-granular timelines and milestones for clinical trial data review and programming tasks (e.g. SDTM/ADaM/TLFs) for CSR and NDA deliverables. This individual will also serve as a cross-study "single source of truth" for the Program Management department for task status for roll-up into master project timelines. In addition, this role will help identify and troubleshoot problems and cross-study resource conflicts. Deep understanding of the activities and workflow of the BCDM function and the clinical trial process in pharmaceutical clinical development required, along with strong organizational and active project-management skills.
Position Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Define and execute BCDM project plans to achieve study and analysis milestones in accordance with the cross-functional integrated master project plan.
Identify and plan BCDM study tasks by defining key milestones and developing achievable timelines.
Monitor progress against the plan and against established process metrics
Drive effective execution of BCDM tasks through by frequent communication and holding functional representatives accountable to timelines
Guide and manage preparation of project milestone review
Provide decision making methodologies, identify bottleneck and inconsistencies within interdependencies and facilitate brainstorming within BCDM to help identify project issues and resolutions.
Develop and maintain standard BCDM task lists, dependencies, timelines, and milestones.
Maintain strong working relationships with BCDM and the Program Management departments.
Manage meetings to include setting agendas, organizing meeting times and meeting minutes.
Execute project management processes and follows best practices in to foster continuous improvement by sharing of knowledge.
Ensure uniform processes/documentation between projects.
May lead process improvement initiatives and change management efforts, together with functional subject matter experts
Perform other duties as assigned

SUPERVISORY RESPONSIBILITIES:
None

EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA in life sciences, science, and/or business administrations;
MS/MA degree in related discipline preferred
Project Management specific training and/or certification desirable

Experience:
Minimum of 3 to 5 years of experience in a CRO, biotech or pharmaceutical setting as a project manager specifically supporting the BCDM functions in clinical development
Oncology experience preferred.

Knowledge/Skills/Abilities:
Excellent understanding of MS Office Suite required.
Excellent understanding of MS Project (or equivalent Gantt software).
Familiar with SmartSheets software.
Strong understanding of the full clinical trial process (oncology is preferred) and the BCDM functions in particular.
Experience with process improvement initiatives, demonstrating keen understanding process mapping, charter creation and meeting management.
Experience with change management including understanding of principles and direct experience with deployment or involvement in change management processes.
Has extensive experience in relevant industry/profession.
Effective leadership, interpersonal and communication skills
Ability to identify solution or pre-empting problems
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has an understanding and wide application of technical principles, theories, concepts and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.

JOB COMPLEXITY:
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.





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Posted: 2020-03-14 Expires: 2020-04-12

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Temporary Project Manager

Exelixis, Inc.
Alameda, CA 94501

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