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Director, clinical study start-up, client oversight (san bovio)

San bovio
Thermo Fisher Scientific
Pubblicato il 3 dicembre
Descrizione

**Director, Start-up Team Managenment - EMEA**

About PPD:
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health!

About the Department:
In Study Start Up, our goal-driven teams combine and deliver startup activities for clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

About the Position:
About our Culture, Career Advancement and Benefits:
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.

**Job Description**:
The role provides strategic direction and fosters a high-performance culture through leadership. Ensures that individual project targets are met, clients are satisfied and services are provided with the highest quality standards and policies and procedures are followed. Cultivates strategic relationships globally and acts a representative across the function and client groups. Contributes to and/or leads initiatives and strategies across the function or organization to optimize service delivery.
- Ensures the timely and customer-focused execution of site activation with a focus on quality deliverables for assigned projects.
- Demonstrates leadership and expertise in supporting, developing and driving the specific and overall site activation strategies to ensure optimum performance and achievement of project plans and targets.
- Facilitates site intelligence and activation planning/kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans.
- Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with Senior Management through appropriate escalation pathways.
- Reviews and assesses team profitability through the identification of “out of scope” activity in a timely manner and supporting follow through on all aspects of contract modification.
- Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date.
- Pro-actively identifies unusual or significant problems encountered during the course of a clinical trial and proposes and implements strategies for preventing or correcting significant problems.
- Participates in business development activities as needed
- Provides ongoing mentorship, coaching and feedback to operational teams and/or staff associated with portfolios
- LI-NA1
- LI-Remote

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous clinical research experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent combination of education, training & experience.

Specific experience in study start-up area

Knowledge, Skills and Abilities:

- Advanced strategic thinking, planning and organization skills
- Capable of analyzing data, anticipating and mitigating risk, exercising sound judgment, problem solving and decision-making working while under pressure and at times with limited desired information
- Skilled at using personal influence and persuasion to effectively promote ideas and proposals to shape stakeholder opinions
- Capable of developing and cultivating strong internal/external networks of contacts and resources to ensure operational execution
- Proven skills in building relationship and working effectively in matrix environments
- Excellent change management skills to influence and motivate, demonstrating excellent interpersonal and conflict resolution skills
- Demonstrated credible leadership style with ability to mobilize and foster team productivity
- Capable of motivating managers and supervisors to define and reach team objectives
- Profiecient in budgeting, forecasting and resource management
- Superior concise and well-organized oral and written communication skills including the ability to communicate in English
- Extremely efficient, well-organized and demonstrates a strong attention to detail
- Excellent computer skills, particularly word processing and spreadsheets (MS Word and MS Excel)
- Deep understanding of study start-up operations in a global environment
- Extensive understanding of FDA, GCP, and ICH guidelines with a track record of successful operational delivery

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