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| Group Leader, Clinical Trial Management Early Development |
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Reporting to the Associate Director, Group Leader Clinical Trial Management (CTM) will assist in ensuring the successful and standardized execution of clinical trials to the required timelines, quality and efficiency to meet the CD plan goals.
Providing suitably qualified and trained CTM Trial Team members in order to input to and deliver the elements of the clinical trials assigned.
Additionally, support the Trial Teams by ensuring that direct reports (CTMs/Clinical Trial Coordinators (CTCs) involved in the preparation, delivery and monitoring of assigned clinical trial adequately fulfil their responsibilities.
Plan and execute trials against the Clinical Development Plan from approved concept sheet to final clinical study report.
Driver/Owner of assigned functional and broader Clinical Development continuous improvement initiatives.
Validate, drive and monitor, with the clinical trial team the key study milestones from launch of the clinical trail team to approved study results.
Resource planning and forecasting and on-going budget management of clinical trials/programs.
KEY TASKS AND RESPONSIBILITIES
Direct line management of a team of CTMs/CTCs in the performance of clinical trial operations and trial execution from First in Man to Proof of Concept (Phase II).
-Accountable for ensuring the standardized and consistent performance of assigned Trial Teams members- CTMs in Clinical Trial Leader role, CTCs, other CTM roles in their role as support to the Trial
-Assigned responsibility for management of training and development budget for assigned staff and contractors
-Serves as coach and/or mentor to all assigned team members
Assists in the development of trial management tools as requested
Assists CTMs in the implementation, and integration of new roles as appropriate and in adjusting/enhancing and incorporating changes to existing roles (e.g. Clinical Trial Leader, Clinical Trial Coordinator), as assigned.
Acts as CTM representative for an assigned Therapeutic Area; provides functional input to CDPs from an operational expertise perspective
Authorizes, monitors and manages expenditure and resource usage against assigned budget
Works independently within the framework established within the CTM management department
CTM representative on all assigned process improvement initiatives
Establishes appropriate communication mechanisms with regions, where assigned staff work to ensure local study needs are met, local HR policies are maintained and local regulations are adhered to
Provides supervisory support to CTM Associate Director and deputises in process improvement initiatives as requested
Training and knowledge resource to assigned team and to new members of CTM
Applies understanding of the overall drug development process and clinical trial project management to anticipate and avert problems before they impact adversely on a project
Contributes to the successful execution of First in Man to Proof of Concept (Phase II) by:
-ensuring studies are appropriately resourced with suitably trained and qualified CTM members
-ensuring ongoing supervision and management of the CTM team and their Trial Teams initiating and participating actively in process improvement initiatives within CD and within Merck Serono
-planning and monitoring clinical trial level activities across Thearapetic Areas and in Merck Serono Medical Marketing Regions as required
Flexibility to take on special projects as assigned
Initiate and participate actively in approved process improvement initiatives within Clinical Development
Operational involvement in conduct of Clinical Trials where appropriate |
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Masters degree (Biological Science/Pharmacy/Nursing)
Other certification (Certification in Clinical Research)
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10 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Geneva |
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Biological Science/Pharmacy/Nursing degree; advanced degree preferred
Certification in Clinical Research highly desirable (US, ACRP or other certification)
Excellent oral and written communication skills in English, other languages an asset.
Minimum 8 years clinical trial management experience in clinical operations role or supplementary experience in relevant related role in the pharmaceutical or biotechnology industry (e.g. regulatory, clinical QA, drug safety, Biometrics/Data Management)
Product development experience and excellent understanding of pharmaceutical development processes
Other relevant pharmaceutical experience would be advantageous (e.g. regulatory, clinical QA, drug safety, Biometrics/Data Management)
Excellent knowledge of ICH GCP and applicable local regulations (e.g. FDA regulatory requirements for drugs or biologics)
Resource Management expertise in either a matrix management role or direct line management capacity
Excellent presentation skills and training experience in a clinical or medical environment
Good understanding of the overall drug development process and clinical trial project management to provide input and support for the Clinical Development planning process.
Good understanding of the contract research organizations (CROs) from both an in-sourcing and outsourcing perspective in order to provide coaching on management of outsourced clinical trials and interface with insourcing agencies
Strong interpersonal skills will be required to ensure the Group Leader can work as a team player and foster a team environment
Good people management, facilitation and mentoring/coaching skills
Exercise excellent judgment, particularly under pressure, in decision making.
Excellent organisational ability and flexibility
Highly self-motivated and proactive
Excellent time and priority management skills
Ability to work as a team player
Conflict management and negotiation skills
Independent decision making |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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