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Senior Initiation Clinical Research Associate (Study Start-Up)

Employer
Parexel
Location
Denmark
Salary
Competitive
Start date
23 Sep 2021
Closing date
14 Oct 2021

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

PAREXEL strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.

This role is office based in Denmark (office-based in Copenhagenor decentralised) & Sweden (decentralised).

The Initiation Clinical Site Manager (iCSM) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCSM can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.

Your Key Accountabilities:
Start-Up (from site identification through pre-initiation)
- Act as PAREXEL's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC and MoH / RA submission/approval,
- Site activation,
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.Qualifications

Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

Knowledge and Experience:
- Previous experience in study set up / site initiation / study start up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology.
- Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable

Skills:
- Strong problem-solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Excellent time management in order to meet study needs, team objectives, and department goals.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a ('virtual') team environment.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Attention to detail.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary as well as a benefits package including 25 days holiday per year, strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.

If you are ready to join PAREXEL's Journey, please apply!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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