Clinical Study Manager Job

CLINICAL STUDY MANAGER needed for a contract opportunity with Yoh's client located in King of Prussia, PA.

What You'll Be Doing:

- Be responsible for the delivery and quality of all clinical studies from protocol concept to final study report and for the validity of all data originating from studies supporting their portfolio, a sub-set of the overall Therapeutic Area (TA) workload.
- Be responsible for reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing.
- Have an established track record of generating alternative solutions and perspectives at project and line level.
- Encourage others within Matrix and line teams to seek alternative perspectives and develop solutions.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and SOPs, for all products and services delivered for their designated studies.
- Make decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate.
- Be accountable for implementing new business processes and strategies; may also proactively identify issues, and propose strategies to manage implications and risks on clinical study/studies timelines, budgets and goals.
- Require active partnership building for their portfolios and collaborate with therapy aligned staff in other functions.
- Interact effectively across boundaries with other global functions using influencing and relationship-building skills

What You Need to Bring to the Table:

- Advanced degree (eg MS, PhD, PharmD) or equivalent experience
- Broad understanding of the pharmaceutical industry and the clinical development process
- In depth knowledge of either study management or data management and knowledge of essential regulatory guidelines worldwide and company policies.
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional Matrix teams.
- Excellent leadership skills
- Excellent influencing and negotiation skills
- Demonstrated experience leading in Matrix environment to deliver projects, develop clinical plans, and manage change

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: SCIENTIFIC

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