|
 |
|
|
| Senior Clinical Project Manager |
|
 |
 |
|
 |
|
To drive and manage the conduct of one or more Early through Phase IV clinical trials in accordance with the approved Clinical Development Plan (CDP)/Medical Marketing Plan (MMP), by executing assigned study responsibilities as the Clinical Trial Leader (CTL) or Clinical Research Manager (CRM). The Senior Clinical Project Manager (SCPM) is an expert in the operational execution of clinical trials so that performance expectations are high. SCPMs should act as Clinical Trial Leaders (CTL - see role description) for one or more pivotal studies and as such manage and drive the overall execution of trial team activities in accordance with the approved Clinical Development plan.
KEY TASKS AND RESPONSIBILITIES
People Management
Lead, direct, support and guide the Trial Team members to ensure study delivery on time, within budget and appropriate quality
Matrix manage functions within Trial Team in CTL role or a subset of functions as support CPM to a CTL
Provide support and direction to external study personnel
Project Management and Execution
As assigned CTL - responsible for validation and feasibility assessment of the trials including contingency planning, implementation of rescue strategy where needed, analysis of trial information and feedback to the CDP in order to ensure Go/No go decisions
Lead and coordinate investigator/site selection and manage/present at Investigator Meetings
Manage drug supply at trial level and interface with members of Trial Team and Clinical Supply Chain coordination team
Define, negotiate and ensure execution of study related SLAs, such as Clinical Trial Agreements, CROS, Central Lab services etc.
Execute trial level activities in accordance with study objectives, budget objectives and quality objectives in accordance with the approved Study Plan
Develop study related documents from concept sheets to final study reports
Liaise with Document Management to ensure maintenance of a compliant Trial Master File
Review clinical trial data during course of study for safety and data cleaning purposes and during trial analysis and reporting
Contribute to review, validate and approve Trial Team documents including Statistical Analysis Plan, Data Management Operational Plan, Data Validation Plan, Trial Team Gannt etc.
Act as an interface for regulatory compliance issues
Manage SAE reporting procedures with Clinical Safety and Pharmacovigilance
Feedback knowledge learned during study to Project Team, CMO Organization, Functions, Global Product Development Units
Maintain excellent scientific and technical knowledge of relevant therapeutic areas and general issues (e.g. critical understanding of laboratory parameters, clinical trial design, compound mechanisms, etc.) |
|
  |
|
 |
|
|
|
|
Masters degree (Biological Science/Pharmacy/Nursing)
Other certification (Clinical Research)
|
|
7 years + |
|
|
|
English : Speak / Write Fluently
|
|
|
|
open-ended |
|
|
|
unspecified |
|
|
|
International |
|
|
|
Geneva |
|
|
|
 |
|
 |
|
|
Biological Science/Pharmacy/Nursing degree; advanced degree preferred
Certification in Clinical Research highly desirable (US, ACRP or other certification)
Excellent oral and written English; other language(s) an asset
Minimum of 3 years experience in project management plus 5 years in related clinical research role (Phases I through IV) in CRO, Pharmaceutical or Biotechnology environment
Experience in executing a wide range of clinical trial activities (start up through final report)
Project management including forecasting and budgeting
Excellent knowledge of clinical trial processes
Sufficient functional knowledge of Trial Team roles
Prior people management experience within a matrix organization
Ability to train and coach new employees
Proven Team leadership skills. Excellent organizational ability.
Highly self-motivated and proactive. Excellent communication skills. Flexible. |
|
|
|
Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
|
|
|
|
