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Clinical Trial Manager

Company Description

PDDN is a provider of end-to-end software solutions and IT consulting Services and software development Company. is headquartered in Fremont, California with clients across the Silicon Valley and other Information technology Hubs in different states. With integrated solutions, software development, technical services, training and staffing support, we help customers achieve their technology goals allowing them to focus on their business.

 

Job Description

Job Title: Clinical Trial Manager

Location: New Jersey

Job Type: Contract (C2C/W2)

Interview: Phone/Skype

Eligibility: GC and USA Citizenship only

Job Description: We're looking for a Clinical Trial Manager to lead and manage clinical trials. This role involves coordinating cross-functional teams, managing vendors, ensuring compliance with GCP and FDA guidelines, and overseeing the entire trial process from initiation to completion. Key responsibilities include developing study plans, monitoring trial progress, managing budgets, and providing leadership to the team.

Skills Required:

  • Proficiency in clinical trial management systems

  • Knowledge of GxP processes (GMP, GLP, GDP)

  • Excellent communication and interpersonal skills

  • Strong problem-solving and decision-making abilities

  • Proficiency in Microsoft Office Suite

  • Ability to travel (up to 25%) and work flexible hours

#Hiring #ClinicalTrialManager #ClinicalResearch #Biotechnology #Pharmaceuticals #ClinicalTrials #GCP #FDA #ProjectManagement #BiotechJobs

Additional Information

All your information will be kept confidential according to EEO guidelines.

Average salary estimate

$100000 / YEARLY (est.)
min
max
$80000K
$120000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Clinical Trial Manager, PDDN INC.

At PDDN, we’re on the lookout for a talented Clinical Trial Manager to join our dynamic team in Hamilton Township, NJ. In this role, you will be at the forefront of managing and leading clinical trials that pave the way for groundbreaking advancements in healthcare. You'll coordinate cross-functional teams and manage relationships with vendors to ensure that our trials adhere to the stringent standards set by GCP and FDA guidelines. You'll have the autonomy to develop study plans, monitor trial progress meticulously, and manage budgets. Your leadership will be crucial in guiding your team through every stage of the trial process, from initiation to completion. With our commitment to providing tailored software solutions and IT consulting, your role as Clinical Trial Manager will be pivotal in helping clients achieve their objectives while ensuring that the technology they utilize aligns perfectly with their trial goals. We require proficiency in clinical trial management systems and a solid understanding of GxP processes, alongside excellent communication skills to foster strong relationships with all stakeholders. As part of our team, you will have the opportunity to make a meaningful impact in the biotechnology and pharmaceuticals sectors. We can’t wait to see how your problem-solving and decision-making abilities will drive success in our trials and contribute to innovative solutions for the future. If you have the skills and passion for managing clinical trials, PDDN is the place for you!

Frequently Asked Questions (FAQs) for Clinical Trial Manager Role at PDDN INC.
What are the main responsibilities of a Clinical Trial Manager at PDDN?

The Clinical Trial Manager at PDDN is responsible for overseeing the entire trial process. This includes developing study plans, coordinating cross-functional teams, ensuring compliance with GCP and FDA guidelines, managing budgets, and monitoring trial progress. Your role involves leading the team to ensure all phases of the trial are executed successfully, making it essential to possess strong leadership and organizational skills.

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What qualifications are needed for the Clinical Trial Manager position at PDDN?

To qualify for the Clinical Trial Manager position at PDDN, candidates should possess proficiency in clinical trial management systems and have a solid understanding of GxP processes including GMP, GLP, and GDP. Strong communication and interpersonal skills, alongside problem-solving and decision-making abilities, are crucial. A willingness to travel and flexibility in working hours is also required.

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How does PDDN support its Clinical Trial Manager's professional development?

PDDN values the growth and development of its Clinical Trial Managers, providing access to training and resources that enhance skills and keep them abreast of industry standards. The company promotes a culture of learning and collaboration, ensuring that our managers have the tools they need to succeed and advance their careers in clinical research.

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What is the expected work environment for a Clinical Trial Manager at PDDN?

The work environment for a Clinical Trial Manager at PDDN is collaborative and fast-paced. You will often liaise with various teams and stakeholders, engaging in necessary travel (up to 25%) and adapting to flexible hours as needed to meet project timelines. This dynamic environment fosters both personal and professional growth.

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What makes PDDN an ideal employer for a Clinical Trial Manager?

PDDN is an ideal employer for a Clinical Trial Manager due to its commitment to innovation and quality in clinical research. The company provides ample opportunities for career advancement, a supportive team culture, and a focus on impactful projects that contribute to healthcare advancements. Our commitment to maintaining compliance and delivering exceptional results sets the stage for your success.

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Common Interview Questions for Clinical Trial Manager
Can you describe your experience with clinical trial management systems?

When answering this question, be specific about the systems you've used, mentioning any particular features you excelled in or challenges you overcame. Demonstrating a thorough understanding of clinical trial management systems highlights your capability to lead trials effectively.

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How do you ensure compliance with GCP and FDA guidelines throughout a clinical trial?

Illustrate your approach to compliance by discussing your experience with documentation, training team members, and setting up monitoring processes. Emphasizing preparedness and foresight in handling compliance will showcase your diligence in maintaining standards.

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What strategies do you utilize to manage budgets effectively in clinical trials?

Discuss techniques such as detailed budgeting, regular reviews, and proactive communication with stakeholders. Providing examples of how these strategies have led to successful budget management in previous roles can strengthen your response.

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How do you handle conflicts within a cross-functional team during a trial?

Share your conflict resolution strategies, emphasizing communication, empathy, and teamwork. Providing real examples of resolved conflicts can demonstrate your ability to maintain team cohesion under pressure.

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What is your approach to monitoring trial progress and addressing issues as they arise?

Your answer should highlight your experience with monitoring tools and regular updates with teams. Discuss specific techniques you use to stay ahead of potential issues and how proactive measures lead to project success.

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Can you provide an example of a clinical trial you led from initiation to completion?

When discussing your experience, focus on the details such as the objectives, challenges faced, and the outcome. This showcases your leadership and operational skills in bringing trials to successful completion.

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How do you prioritize tasks during a busy clinical trial?

Outline your methods of prioritization, including task management tools and communication with your team. Providing a clear structure shows your ability to maintain organization amid competing demands.

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What is your experience with vendor management in clinical trials?

Discuss how you've effectively engaged and managed external vendors, emphasizing contracts, performance assessments, and fostering strong partnerships to ensure deliverables align with trial objectives.

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What qualities do you believe are essential for a successful Clinical Trial Manager?

Highlight key qualities such as leadership, adaptability, attention to detail, and excellent communication skills. Providing examples of how you've demonstrated these qualities can set you apart as a strong candidate.

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Why are you interested in working as a Clinical Trial Manager at PDDN?

Express your enthusiasm for PDDN’s mission and the unique opportunities offered within the role. Connecting your career goals with the company's values demonstrates your genuine interest in contributing to their success.

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PDDN is a provider of end-to-end software solutions and IT consulting Services and software development Company. is headquartered in Fremont, California with clients across the Silicon Valley and other Information technology Hubs in different stat...

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Contract, on-site
DATE POSTED
December 23, 2024

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