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| Group Leader, Clinical Trial Management Early Development |
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The Group Leader will assist in ensuring the successful and standardized execution of clinical trials to the required timelines, quality and efficiency to meet the Clinical Development Plan (CDP) goals. Providing suitably qualified and trained Clinical Trial Management Trial Team members in order to input to and deliver the elements of the clinical trials assigned. Plans and executes trials against the CDP 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. The Group Leader may also act as Clinical Trial Leader (CTL) for one or more clinical trial(s).
Functional Tasks
Leads, manages and drives the planning and overall execution of the clinical trial.
Ensures that the trial is performed to the high standards of quality according to agreed timelines and approved budget.
Leads and oversees activities of the trial team.
Oversees Contract Research Organizations (CROs) and other vendors in an outsourced trial.
Ensures implementation of standard Clinical Development processes across of Clinical Trial Management Early Development (CTM ED) team member.
Reviews and approves clinical trial related documents as required by Company Standard Operating Procedures (SOPs) & Work Instructions (WIs) and conventions.
Assists in the development of trial management tools as requested.
Is the CTM ED representative on all assigned process improvement initiatives
Analyses resolve complex problems independently and coach and train others to do so
exercise excellent judgment, particularly under pressure, in decision making.
Contribute 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 process improvement initiatives within R&D and within Merck Serono
contributing significantly to CD in all TAs as required.
Initiate and participate actively in approved process improvement initiatives within R&D
Operational involvement in conduct of Clinical Trials where appropriate/assigned.
Ensures that performance of assigned CTM ED team member is of adequate quality and assigned work is performed within agreed timelines and regulatory requirements.
Managerial Tasks
Leads and manages assigned CTM ED team of ACTMs/CTMs/CTCs in the performance of clinical trial operations and trial execution from First in Man to Proof of Concept (Phase II).
Serves as coach and/or mentor to all assigned CTM team members.
Accountable for ensuring the standardized and consistent performance of assigned Trial Teams members - CTMs in CTL role, CTCs, other CTM roles in their role as support to the Trial Teams as applicable.
Ensures the appropriate resourcing of clinical trials First in Man to Proof of Concept (Phase II) for ACTMs/CTMs/CTCs as applicable.
Manages administrative matters associated with assigned CTM team members including trial assignments, expenses processing, travel & training requests, recruitment as directed.
Ensures clinical trial status updates at the requested frequency and format are provided by assigned CTM ED team member.
Sets Goals and Objectives in line with GCO balance scorecard and study objectives for CTM ED team members with input from appropriate internal departments. Monitor and manage performance on an on-going basis. Review performance appraisal on at least a 6 monthly basis. Conducts annual salary review in consultation with Associate Director CTM ED.
Identifies training and development needs and ensures the appropriate training and development of CTM ED team members. Training responsibilities include Clinical Development and Company SOPs and WIs, ICH/GCP and applicable local regulations are provided and documented, as required.
Ensure that training to enhance professional development is performed in accordance with Merck Serono Compass Competencies and as required for Trial Team role.
Review working practices of the CTM ED team members on an on-going basis and provide active coaching, and mentoring as required.
Assigned responsibility for management of training and development budget for assigned CTM ED team members (and contractors).
Works independently within the framework established within the CTM ED management department.
Authorizes monitors and manages expenditure and resource usage against assigned budget.
Provides supervisory support to CTM ED Associate Director and deputizes in process improvement initiatives as requested. |
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Masters degree (Biological Science/Pharmacy/Nursing)
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15 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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International |
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Geneva |
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Minimum 9 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 Quality Assurance, 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)
Good people management and training/mentoring skills and/or experience
Proficient PC skills: Word, Excel, PowerPoint, e-mail, databases
Excellent oral and written communication skills in English
Other languages an asset
Expert knowledge of Clinical Operations and Clinical Development processes as well as ICH/GCP and applicable regulations
Excellent knowledge of project management in clinical trials
Solid experience in all aspects of clinical trial conduct (including budget and resource planning), and in the execution of the complete range of activities in a multinational clinical trial, from start up through to final clinical study report
Expected to continuously review working practices of direct reports, address any deficiencies and provide coaching and mentoring as required
Supports and/or manages interfaces with external functions/groups including service vendors and clinical site personnel
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
Sufficient knowledge of all Company therapy areas to enable appropriate input to study documents e.g. protocols, CRFs, EDC development, CD Plans, and provide coaching and mentoring to all assigned Trial Team members
Good understanding of the contract research organizations (CROs) from both an insourcing and outsourcing perspective in order to provide coaching on management of outsourced clinical trials and interface with insourcing agencies
PERSONAL SKILLS & COMPETENCIES
Works as a team player and foster a team environment. Highly self-motivated and proactive
Open-minded; Strategic thinking beyond own function; is familiar with and takes into account overall business objectives and company strategy
Communicates effectively with internal and external clients and senior management. Able to manage conflict and has excellent negotiation skills
Able to see the "big picture" (beyond clinical operations)
Excellent time and priority management skills; Independent decision making. Excellent organizational ability and flexibility
Be open to change
Strong interpersonal skills. Leads and manages assigned CTM ED team
Has good people management, Serves as coach and/or mentor to all assigned CTM team members |
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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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