Project manager/ International Project Manager

Are you looking to advance your career in the clinical drug development field? Are you looking to play an integral role in the future of medicine across the globe? Do you want to work for a leading early phase clinical research organization, renown throughout the industry for its capability to perform complex phase I/II clinical trials?

This is an excellent opportunity for a project manager who would like to expose to the international field of clinical trials and actively contribute to the development of innovative medicines.

Description of the position

The legal aspects of clinical trials are governed by Good Clinical Practice (GCP) Guidelines. The conduct of clinical trials is described in detailed protocols, which govern the activities of the staff involved in the trial.

The Project Manager is the responsible person that ensures the project is conducted to the highest standards, quality and in accordance with the agreed timelines and budget. Furthermore, the Project Manager acts economically orientated to organize the projects successfully.

The Project Manager is the first-line contact person for all involved persons and parties, institutions and Sponsors.

Main Responsibilities

• Responsible for overall management of the trial conduct, as main point of contact and interface between Sponsor and ARENSIA Departments and Vendors – in compliance with ICH-GCP, ARENSIA SOPs, as well as national and international regulations. Takes the overall project management in case of annual leave or sick leave or in case of change of the assigned Project Manager

• Supervision of trial timelines (project progress reports, tracking tools) to ensure a qualitative and timely performance of tasks according to the project contract (planning, general management, control)

• Management of and communication of changes (amendments/change orders) during a running project to the line manager, contract manager and general management (if applicable)

• Communication of significant and/or critical changes regarding timelines and costs and critical quality issues towards the line manager and general management (if applicable) with subsequent analysis of the situation and suggestions for resolving problems

• Communication to sponsor in a quick and responsiveness manner (. an e-mail shall not stay without answer more than 24 hrs from receipt)

• Communication to external parties (. consultants, collaborating physicians, vendors etc.)

• Involve and manage ARENSIA personnel from different departments as necessary for a successful trial conduct

• Ensure confidentiality of the appropriate information

• Input to prepare and/or adopt trial protocols and informed consent forms

• Preparation of submissions to the Ethics Committee and to the Regulatory Authorities, contact with authorities

• Preparation, maintenance and archiving of internal and external documentation

• Ensure availability of necessary material and equipment for trial start

• Feasibility research for potential new trials, identification and selection of investigator sites, primary contact with the sites

• Input to contract negotiation with 3rd parties/subcontractors

• Management of investigator meetings

• Co-management of patient recruitment strategies

• Support of Investigators in AE/SAE reporting

• Audit hosting as applicable and required

• Answering of audit reports and implementation of CAPAs following respective trial audits

• Participate in review and development of internal standard documentation (SOPs, forms, instructions, templates etc.)

• Involvement in business development activities ("client care")

The Candidate

•  Project management activities require excellent communication skills, especially in dealing with Sponsors and ARENSIA trial team members

• A very good understanding of the pharmaceutical and biotechnological industry and the services provided by ARENSIA is mandatory

• Project Managers must be able to motivate, organize and lead a team

• Project Managers must have the competence to organize and plan timely activities and resources as well as managing the interaction between the client's needs and internal team processes

• Project Managers are responsible to build up and maintain good relationships to clients, third parties and team members

• In addition, team spirit, reliability, discipline, accuracy and quick reaction time with "solve" mentality is required

• Strong quality orientation including the ability to focus on details

• A willingness to travel occasionally is also required

• Project Managers have a good knowledge of local legal requirements/laws and ICH GCP guidelines for conduct of clinical trials

• Project Managers must have a high flexibility, profound background of medical/natural scientific knowledge and a solid understanding of the different types of trials and investigational drugs

• Project Managers are mainly medical or natural scientifically educated

• Fluent oral and written English language

• Comprehensive knowledge in the MS Office Suite (small business)

No experience in clinical research required. Candidate will go through an extensive training program.

Package Description

• attractive salary package

About ARENSIA: we are a German clinical research organization with HQ in Dusseldorf, specialized to perform early phase clinical research trials in various disease areas with outstanding reputation across the industry for safety and quality. Please visit our web for more information:www,arensia-em,com