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Senior Project Manager, Germany - L

Employer
ClinChoice
Location
Germany
Salary
Competitive
Start date
10 Feb 2021
Closing date
11 Mar 2021

View more

Discipline
Project Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
Job Title: Senior Clinical Project Manager

Location: Home or office based, Munich, Germany

Schedule: Permanent, Full-time

Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, are looking for a dynamic person to join our in-house team. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.

As a Senior Clinical Project Manager you will be responsible for oversight of assigned clinical projects ensuring quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines and other applicable regulations. You may also act as Project Director/Leader, depending on the complexity of projects.

Main Tasks and Responsibilities
  • Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team members
  • Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state
  • Manages the budget of the project
  • Participates in Monitor's and Investigator's Meetings
  • Provides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.
  • Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor
  • Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations
  • Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels
  • May provide oversight and mentoring for junior staff assigned to the projects.
  • Supervises the archiving activities
  • Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)
  • Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs)
  • Performs, if necessary, co-monitoring visits for the assigned clinical projects;
  • May act as Feasibility Associate (FEA) after appropriate and documented training
  • May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)
  • Arranges and collaborates with the assigned Clinical Research Department Director, in identifying the project specific trainings of the project team and in delivering them


Education and Experience Required
  • University Degree in scientific, medical or paramedical disciplines
  • Significant experience in clinical project management in the CRO/pharmaceutical industry
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Fluent in English and local language(s)
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying please contact Myna.Yeboah@cromsource.com for more information, or alternatively please apply through our website at https://www.cromsource.com/careers/job-vacancies/job-information/?job-id=HQ00002405

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Senior Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead

Skills: CSR, Feasibility, GCP, ICH-GCP, Monitoring, MS Office, Project Management Location: Germany Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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