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Global Clinical Project Manager - Finland

Employer
Labcorp
Location
Helsinki, Finland
Salary
Competitive
Start date
12 Nov 2019
Closing date
18 Nov 2019

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Covance is looking for a Global Clinical Project Manager to be based in Finland. This is a Client-dedicated role, 100%.



Position Purpose:



The overall objective of the Study Manager in the Oncology Strategic Business Unit is to manage the planning, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals. Typically the studies managed by the Lead StM are highly complex and/or strategic priority clinical studies; characterized by challenging protocol/study designs, atypical study operations, high study financial costs, large global clinical trial scope and/or new areas of investigation.



Geographical Scope: Global



Major Tasks:



1. LEADER OF THE GLOBAL STUDY TEAM
Identifies, implements, leads and manages a global, cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. Leads the yearly goal setting process for the study(ies) in scope in close collaboration with study team and clinical team members
Represents the study team as a member of the Global Clinical Team
Disseminates relevant information to study team in an effective and timely manner
Chairs study team meetings and investigator meetings, holds vendor kick-off meetings
Develops in cooperation with respective functions appropriate study related training for study team representatives and site personnel according to GCP and BAG Pharmaceuticals development standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met.



2. FEASIBILITY
Supports protocol feasibility; leads the operational planning and tracking of the site feasibility
Reports status, issues and important feedback to GCT
Supports analysis of feasibility data
Based on the feasibility summary, develops study timelines incl. enrollment projections, milestones and proposed external study budget



3. MANAGE STUDY ACTIVITIES
The Lead StM manages all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted in high quality and within the given timeline and budget.
Manages the possible changes in project scope, timelines and budget
Develops and implements patient recruitment and retention strategy in close collaboration with the study team.
Supports development and implementation of integrated data review plan (IDRP) as well as ongoing data cleaning as defined in the IDRP
Responsible for set-up, regular filing and completeness of study documentation (TMF)
Liaises with various functions to ensure seamless study conduct throughout set-up, maintenance and closure and initiates actions to resolve issues.
Supports during Authority Inspections and internal audits and is responsible to get study conduct related findings solved.



4. PREPARATION OF DOCUMENTS
Provides operational input and insight into the preparation of the study protocol and contributes to other core study documents in close collaboration with the study team
Develops the comprehensive overview and operational plans for the study such as the Study Plan, Oversight Plan etc.



5. TRACKING AND REPORTING
Measures study performance using appropriate systems, tools and techniques
As a team member of the Global Clinical Team (GCT), the Lead StM provides input to the GCT to enable accurate tracking and management of the overall Clinical Development Plan (CDP).
Establishes study milestones with the study team and ensures accurate tracking and reporting of study metrics such as recruitment projections, patient enrolment, data cleaning progress and overall study progress.
Oversees forecasting of clinical/non-clinical supplies



6. RISK IDENTIFICATION AND HANDLING
Leads study risk levelling and risk mitigation strategies
Contributes to risk management activities of GCT
Assesses and analyses study information for variances and takes necessary actions within his/her responsibility to resolve variances, if necessary
Responsible for study specific oversight
Can be assigned as responsible person for the study risk profile ensuring appropriate follow up of mitigation actions agreed at KOMs and FU meetings
CAPA (Corrective And Preventative Action) identification and follow up



7. PLANS AND TRACKS STUDY BUDGET
Responsible for developing and tracking the total external study budget and accountable for providing monthly, quarterly and yearly estimates information to the Clinical Team and to Controlling.
Forecasting study budget in close cooperation with the Resource Management and System Integration (RMSI) group.
Communicates variances in the budget and action plan for resolution to the Clinical Team



8. MANAGE EXTERNAL VENDORS
Acts as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.).
Defines outsourced tasks and develops contract specifications for external supplier in collaboration with global strategic sourcing manager.
Liaises with quality functions to ensure vendors are qualified.
Performs ongoing vendor management, including negotiation of scope of work, budgets (incl. change orders), performance management, and issue resolution.
Identifies milestone achievements to initiate payments to vendors.
In case the Lead StM is assigned to an out-sourced program under a POM (Partnership Operational Manual) the Lead StM acts as an \u2018oversight manager'. This is an assignment not a job title. The Lead StM may assume responsibility for bigger, high priority POM studies. The distribution of tasks is done based on the POM.



9. SYSTEM MAINTENANCE AND CONTINOUS IMPROVEMENT
Ensures all relevant IT-systems are updated with current and accurate information (e.g. IMPACT, CTPS).
Chairs or participates in expert working groups, project standard teams etc.
Drives or contributes to global process improvement efforts



10. ADDITIONAL TASKS: STUDY OPERATIONS
May lead, motivate and inform country teams
May ensure training and oversight of monitoring
May track and report operational progress
May develop additional operational plans.




Education/Qualifications:
The incumbent must have a Bachelor's degree or equivalent education plus 8+ years of relevant healthcare experience including 5 years clinical operations in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience.
Experience:
The incumbent is responsible for management of highly complex Phase I-IV global clinical trials. This requires an in-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations) with a proven track-record leading the initiation and completion of clinical studies.



The position also requires ability to successfully achieve results within a multi-cultural and geographically diverse team, and capability to create team culture and promote team spirit. The incumbent requires comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters.



Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills are required. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through. The Lead StM is able to manage conflicts in the team effectively.
Locations:
Helsinki, Finland

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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