Clinical Manager I / II (Medical Devices)

Premier Research
10 Oct 2018
15 Oct 2018
Contract Type
Full Time
Role: Clinical Manager I / II (Medical Devices)

Location: office based in one of our European office locations or home based

Contract Type: Permanent

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

We’re looking for a Clinical Manager I/II to join our team! This is a permanent role to be located in any of our European offices. This role requires experience in Medical Devices.

Imagine. Inspire. Innovate. Impact. With Us.

You'll be accountable for:

Ensuring the effective selection, initiation and motivation of clinical study sites
Planning and driving patient recruitment and retention
Ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements
Taking the initiative to move the project/program forward and leads in country and global projects where applicable
Customer focused on both internal and external customers
Leading and managing the clinical start-up and monitoring teams with focus on deliverables
Supporting Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents
Working with the Project Manager (PM) to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
Planning and conducting initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable
Developing a clinical monitoring plan as well as clinical monitoring tools
Preparing and executing a site and patient recruitment and retention plan
Driving the successful activation of trial sites according to time, quality/scope and budget parameters
Serving as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required
Ensuring effective communication plans are in place for the clinical team and are actioned
Monitoring the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues
Monitoring the quality of clinical deliverables and addresses quality issues with the appropriate team member
Working with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
Escalating issues and provides escalation path for the team
May serve in a dual CM/PM role on smaller studies

You'll need this to be considered:

Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required.
Fluent in verbal and written English; and fluent in host country language
Strong experience in clinical trial management
Experience in Medical Devices is required
Experience in managing complex or global trials
Budget/finance experience on a project level and demonstrates a full understanding of project financials
Experience in developing a Clinical Monitoring Plan
Ideally you will have experience attending bid defenses
This will ideally be located in one of our European offices

You must be eligible to live and work in the specified country in order to apply for the role.

KEY WORDS: Clinical Manager, Clinical Trial Manager, Clinical Team Lead, Lead CRA, Study Manager, Permanent, CRO, Contract Research Organization, Clinical Trials, Clinical Research, Pharmaceuticals, Office Based, Remote Based, Home Based

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