Head of Project Management - Berlin, Deutschland - emovis GmbH

Beschreibung

Mission

Are you interested in working in a Decentralized Clinical Trial (DCT) Team, where you will be involved with the operational team, Project Managers, Homecare Trial Coordinators, and other Stakeholders within and out of FutureMeds? Are you eager to work in a dynamic and international team with flexible working hours? Come and be part of us.

This position can be 70% remote as some travelling is expected.

What you will be a part of:
emovis is since 2001 a dedicated study site right in the center of Berlin, conducting out-patient clinical studies to assess the efficacy and side effects of new medications. Participation in a clinical trial can mean quite a burden for some patients (long travel time, exhausting and frequent examinations) and even not being possible for other (severely diseased patients, kids that need to go to school...). If the patient cannot go to the study site, we bring the study site to the patient with our Homecare visit department. From our office in Berlin, we organize and coordinate homecare visits for patients in 16 European countries.
Since August 2023, emovis GmbH is now part of the FutureMeds network and this role will not only revolve around emovis in Berlin, but around the different FutureMeds DCT networks in the world.

We are looking for a new colleague for the position of Head of Project Management & Compliance.

Ihr Profil

What you can expect:

1. Project Management and Delivery; Projects and Team Leadership & Coaching

• Provide leadership to the Project Managers and Homecare Trials Coordinators, continuous development and coaching of the team to ensure the highest project delivery even in the face of the ambitious schedules and discouraging developments and client relationship standards.
• Effective and motivating performance management with Project Managers and Head of Home Trial Coordinator, agreeing meaningful objectives, goals and strategies.
• Reasonable and cost-effective resource and capacity planning.
• Support and oversight of the project's budgets and WO and CO negotiations with the goal of effective closure and possible fast start of the projects.
• Operational Development: continuous improvements of the supporting tools, processes, working instructions, with the goal of simplification of the utilized tools, streamlined processes and effective approaches.
• Effective Project communication pathways across the involved teams and with the external stakeholders to ensure the project information is clear, transparent and delivered within the required timelines, and high quality and communication standards.
• Define and implement the escalation pathways to ensure the global internal and external stakeholders are properly informed about the project status and proactively informed about any identified risks or critical status.

2. Client Relationship Management

• Build effective and robust client relations and manage the interactions between the customer's team and the rest of the FutureMeds study team.
• Maximize the business potential with the clients: numbers of WO's and CO's per client, maximal WO execution, number of countries and sites supported withing the projects and scope of the provided services
• Support of the strategic initiatives to ensure the continuous improvements of the provided services and continuous improvements of the collaboration with the clients.

3. KPIs and measurement

• Change Management to support the teams with successful implementation of the optimized process and new implemented tools.
• Support of implementation of new systems/reports incl. Team trainings to ensure the proper utilization of the system.
• Regular operational reports to monitor the study delivery trends and maximize the WO execution.
• Monitor risks / issues report across all countries and providing guidance for RCA's and CAPA process, to ensure the timely resolution.
• Further development of quality standards and process based on the automated monthly QI reporting.

4. Regulatory Compliance & Quality Support

• Support with the creation of the regulatory intelligence data across all countries for all business models to ensure the regulatory compliance and to guide the clients if needed.
• Collaborate with Project Management on the escalation of any quality issues raised by the clients, support (if needed) with smooth and effective resolution.
• Ensure compliance with company quality framework, regulatory (GCP) legislation, guidelines and international standards.

What we are looking for in you:

1. Professional Skills (Education, Training, Knowledge, and Experience)

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• In depth knowledge and understanding of the requirements, best practice and organization of Project's in clinical research.
• Worked as a Senior Quality/Project Manager/Director for a minimum of 2 years.
• Able to effectively manage quality issues incl. root cause analysis and delivering effective CAPA.
• Experience in training other members of staff at all levels.
• Able to work independently, with minimal supervision, and be confident to make global decisions and escalate accordingly.
• Willingness to travel globally as needed.
• Exceptional customer services skills to both internal and external stakeholders.
• An understanding and experience of working within a matrix management environment.
• Experience of working within a highly regulated environment.
• Personal skills including assertiveness, persistence, flexibility, highly organized and detail oriented.
• Experience in managing stressful situations and handling controversial issues whilst firmly adhering to the principles of the regulations and guidelines.
• Expertise in reviewing, revising and writing Standard Operating Procedures.
• Able to manage projects/ teams, incl. meeting all deliverables and timelines.
• A degree or relevant qualification e.g. diploma, certificate, or relevant experience in clinical trials.
• Excellent verbal and written communication skills in English

2. Communication and influence

• Strong Team Player
• Excellent communication skills and the ability to manage upwards and to interact with management level successfully.
• Listen actively to colleagues and external contacts and clarify as appropriate.
• Good interpersonal and organizational skills and excellent communicator to both internal and external stakeholders.
• High level of professionalism and customer service orientated.

3. Confidentiality

• Understand requirements and maintain commercial confidentiality.

In a nutshell, we are looking for someone that is engaged, motivated, and an effective leader in terms of project management and homecare visits. Someone who has a track record of successfully managing project risks and support the implementation risk mitigation plans, while always staying at the top of GCP guidelines and compliance issues in the clinical research world. A team player who aims to maintain 100% accurate reporting and has positive client relationships (communication on time, professionally managed and prepared meetings to name a few).

Warum wir?

What we offer:

• Working in an experienced team with several fascinating facets of the clinical research world
• Career and development opportunities
• Open-ended contract
• Full time employment, 40 h/week
• Dynamic work in a motivated team
• Flexible working hours
• Remote office is possible with some travelling expected
• Salary will be negotiated upon qualification
• 30 days of holiday

Please apply via e-mail (incl. salary expectations and availability to start) at Your contact person will be Mrs. Nicole Bohrmann, Director of Decentralized Operations at FutureMeds. Looking forward to hearing from you

Über uns

emovis – das sind etwa 80 engagierte Mitarbeiter*innen, die sich auf 4 Abteilungen verteilen. Auf unserer Fahne steht geschrieben, die zukünftige Medizin mitzugestalten: So tragen wir mit unseren klinischen Studien dazu bei, wirksame und sichere Medikamente zu entwickeln, die gesundheitliche Leiden lindern sowie Leben retten können. Schon seit vielen Jahren schätzen uns unsere Geschäftspartner*innen für unsere schnelle, qualitätvolle und zuverlässige Arbeit.

Was uns bei emovis ausmacht:
Wenn Sie bei emovis zu arbeiten beginnen, werden Sie schnell feststellen: Wir legen keinen Wert auf verstaubte Konventionen, sondern auf Individualität. Wir vertrauen auf und fördern die Stärken unserer Mitarbeiter*innen – bei uns werden Sie Freiraum finden, um selbstverantwortlich arbeiten und eigene Ideen einbringen zu können.

Diese Haltung werden Sie auch an unserer Kommunikation erkennen: Gleichermaßen professionell und herzlich miteinander umzugehen ist für uns kein Widerspruch, sondern selbstverständlich.

Bei emovis gilt: Stehenbleiben ist keine Option. So strecken wir unsere Fühler nach allen Seiten aus und entwickeln uns stetig weiter. Hierbei werden wir Sie als wertvollen Teil unseres "Puzzles" zu schätzen wissen.