Senior Clinical Project Manager

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. Germany
Berlin, Germany
Posting date: 03 Dec 2020

Proclinical has partnered with a successful pharmaceutical company in search for a Senior Clinical Project Manager in Germany. This role will be Homebase and the PM will be expected to assume full accountability for project delivery on time, with quality and on budget. Standard Operating Procedures, Good Clinical Practices, local laws and regulations must all be in alignment.

Job Responsibilities

  • Takes full leadership on all project deliverables on projects assigned as gPM (or rPM on given project for specific countries, if business demands)
  • Ensures that project deliveries are on time, within budget and with quality
  • Proactively identifies areas for process improvement and provides suggestions on process changes
  • Builds and manages the study budget, implement actions to mitigate areas of risk, drive delivery across the full project, collaborate with internal stakeholders to track study progress and create study tools
  • Analyzes Study Protocol (or study assumptions and Sponsor's needs in case Protocol is not available), in order to define scope of services for internal and external Providers project success and identify risks from the beginning of the project
  • Coordinates and manages project start-up, project maintenance, and project close-out activities
  • Effectively drives client and internal team communication
  • Provides leadership to KCR study team members as well as relevant vendors
  • Proactively and effectively communicates with assigned team members across relevant functions in order to drive project success; aims to be instrumental in the management of the client via close collaboration, both in person and remotely
  • Sets up all relevant study plans and keeps them updated throughout the study execution
  • Communicates updates to project scope and/or timelines to all parties involved
  • Leads teleconferences and meetings with Sponsor, Services Providers and Managers from other departments
  • Takes ownership of project issues and proactively drives to resolution, including relevant escalation as needed
  • Follows applicable SOPs and regulations and drive team compliance
  • Maintains study status tracking tools up to date and drives team member's compliance
  • Prepares reports on the assigned activities according to the requirements and timelines established by supervisor
  • Proactively communicates project status, issues & risks to stakeholders and management
  • Closely collaborates with Project Finance Management in the project finance oversight and addresses issues/incompliances immediately until resolution. This includes but is not limited to: verification of budget offer, accurate reporting of study costs by Services Providers, overseeing value of pass through costs and CRO remuneration, reacting immediately to deviations or changes that may have impact on budget realization and proposing Change Order, controlling financial aspects of projects within assigned project portfolio
  • Leads activities in Investigators Meeting preparation and conducts it; agrees on meeting agenda and the list of presentations, participates in the meeting as a host and presenter
  • Delegates skillfully and seamlessly operational study tasks to other study team depending on their ability to perform the task
  • Provides mentoring to APL/PLs and more junior Project Managers
  • Performs Site Engagement visit to assigned country in line with CCOS strategy

Skills and Requirements

  • University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
  • Significant experience in project management of clinical trials (minimum 1 year of Project Management experience)
  • Previous or current CRO/sponsor experience or Medical Device Manufacturer experience
  • Broad knowledge of medical terminology, clinical patient management and clinical research
  • methodology
  • Advanced team leadership skills
  • Advanced decision-making skills
  • Demonstrates sound judgment in decision making process and has strong understanding of scope of contracts, including milestones and recognition of changes
  • Measurable knowledge of Good Clinical Practice (GCP) requirements and local regulations for
  • conducting clinical trials
  • Solid analytical, negotiation and communication skills

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.