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For more information speak to Danielle Boniface on 01707 817313

To apply by email danielle.boniface.65962.10471@justpharma.aplitrak.com

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Clinical Trial Leader x2Ref: BBBH4438

Salary:Up to £0.00 per annum

Added:25 Oct 2018

Region: Germany

Category: Clinical Research

Just Pharma are currently recruiting on behalf of a Biotechnology within Munich Germany, who are searching for a Project Manager

Project Manager leads the Clinical Trial Team in planning, executing and reporting on global phase I-IV clinical trials from trial start-up through trial close-out, in compliance, ICH GCP and regulatory requirements under the supervision of Program Operational Leader.

YOUR RESPONSIBILITIES:

Leads Clinical Trial Team (CTT) in operationalizing protocol

Creates trial level timelines and ensures all trial deliverables are met with high quality on time and within budget

Ensures all trial related documents including operational plans and systems (e. g. clinical database, IRT and etc.) required for Ethics / Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines

Manages trial allocation and coordination / management of activities leading to selection and initiation of sites

Ensures trial-level and site-level readiness for first site initiation

Plans, drives and facilitates investigator meetings or equivalent investigator training with CTT and vendors

Prepares, implements and manages vendors including their sub-contractors and ensures oversight of trial activities outsourced to the vendors in collaboration with CTT

Manages and coordinates Investigational Medicinal Products (IMP) and non-drug supplies across regions and countries and ensures final drug accountability

Manages overall trial conduct to trial close out in coordination with CTT and vendors

Collects, tracks, and communicates trial status for enrollment, timelines, data entry / queries, trial materials; provides updates to relevant internal / external boards

Manages trial budget including completion of grant plan specifications, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out

Collaborates with Clinical Program Leader to define the scope of responsibilities of operational and medical / clinical data review within the data management plan or equivalent to ensure ongoing quality data review

Provides operational support for clinical study report (e. g. appendices)

Ensures complete close out of all sites (vendor materials, budget)

Ensures inspection / audit readiness including trial master file documentation

YOUR REQUIREMENTS:

Ideally min. five years operational experience in planning / executing / reporting clinical trials

Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process

Experience with health authority inspections (FDA and / or EMEA) preferred

Demonstrated ability to effectively manage trial budget

Strong leadership and project management skills

Excellent in negotiation and conflict resolution

Ability to influence without authority

Ability to lead a global cross-functional team (including external partner) in a matrix environment

Strong interpersonal skills

Ability to work under pressure

Resolve issues independently and understand when to escalate

Fluent English (oral and written)

WE OFFER:

Creative working in X-functional teams

Open and appreciative corporate culture

Multicultural environment

Working in an attractive, high-quality equipped building with restaurant

Free sports and language courses

Please get in contact with Danielle +441707817313 or email

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