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| Senior CRA |
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* To oversee the conduct of clinical trials, within the agreed time‑scale
* To represent Global Clinical Monitoring (CM) on the Trial Team for insourced or outsourced trials, and operate as central communication channel between Trial Team and the Clinical Monitoring Department
For outsourced trials
* To co-ordinate the agreed level of CRO surveillance activities. Acting as a channel for the trial team to report and address any escalated issues flagged by the CRLs
* To represent Global Clinical Monitoring (CM) on the Trial Team and be the CRO contact for monitoring input:
- Provide input and feedback on CRO Bid Proposals, feasibilities ,site selection/recruitment plans, EC/HA submission plans
- Provide input and feedback on Trial Team generated documents (e.g. Delegation of Activity Communication Plan, CRO Scope of Work, Protocol, study plan) and feedback on any CRO
Prepared documents
- Provide a site surveillance plan
- Act as a link between the CRO and CRLs/CMMs, for communication regarding specific local issues
- Provide updates and act as a source of trial knowledge on an ongoing basis to the CM department from: trial team meetings, CRO status reports regarding site selection from start up phase throughout the study
For insourced trials
- Collection, input and review of study documentation
- Validation of Key Study Milestones (e.g. start-up timeframe, recruitment targets, data collection, data cleaning, database closure) to be performed by all Monitors
- Organization of CRA trainings
- Implementation of the Enrollment plan
- Responds to any Monitors questions and provides feedback, participates in site evaluation and initiation visits as necessary
- Active participation in Investigator Meetings
- Acts as a communication channel to and from Monitors to ensure site management and site quality is maintained to all required regulatory and ethical standards throughout the study
- Review and provide input on requested trial documentation(e.g. Protocol, Informed consent, diaries and other study documents as requested)
- Coordination of the generation and input of study related forms in accordance with standard templates
- Adapt and maintain Monitoring study tools (E.g. Study action plan, site action plan & status report; CRF Completion Guidelines, Monitoring Plan, submission plan…)
- Study communication tool development (e.g. newsletter)
- Coordination of EC/MOH submission activities with the LSR team |
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Bachelors Degree (Biological science/pharmacy/nursing degree or Nursing qualification)
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7 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 or Nursing qualification
* Minimum 5 years CRA experience or combination of CRA + other relevant experience (e.g. regulatory, clinical QA, pharmaceutical sales, study site coordinator)
* Proven track record demonstrating thorough knowledge of ICH GCP and applicable local regulations (e.g. EU/ FDA regulatory requirements for drugs or biologics)
* Experience in relevant therapeutic areas
* Experience of internal audit
* Involvement in protocol, CRF, other trial related document development
* Understanding of drug development process
* Excellent oral and written communication skills in English; other language as appropriate for country
* Phase I to IV experience
* Experience of regulatory inspection
* Multinational experience
* Evidence of creative problem-solving skills
* Proficient PC skills: Word, Excel, PowerPoint, e-mail
* Excellent organisational ability and flexibility
* Strong interpersonal skills
* Highly self-motivated and proactive, with a keen attention to detail
* Excellent time-management skills
* Goal orientated, able to effectively prioritize and execute tasks in a high-pressure environment
* Ability to be a team player
* Ability to work from home
* Be willing and able to travel
* Be willing to aid CM in cross-regional resource roles where mutually convenient |
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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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