- Ensuring clinical trials are effectively executed and completed within budget,
timelines and meeting enrollment commitments as well as routine updating of clinical
systems. Pro-active trial management to identify challenges, develop effective
mitigation plans and to appropriately escalate and inform all relevant parties.
- Ensuring management of trials are done in compliance with ICH, GCP, local laws and
regulations. To maintain quality standards, the CPM is involved in additional protocol
specific training and might be supporting co-monitoring with a CRA. Providing country
specific guidance and oversight to CRO's where needed.
- Manage site pre-selection and validation process. Support local investigator meetings,
ensure contracts and applicable reg documentation is obtained prior to study start.
Facilitation of all aspects of IRB/ERC and Regulatory Agency submissions (including local IC).
PPOC for all logistical and operational issues and facilitate general communication.
- Oversee drug and clinical supplies management to ensure sites have timely availability
of required materials to avoid disruption of protocol deliverables
- Ensure clinical study site close-out in accordance with local regulations and ensure
dissemination of clinical trial results to the participating study investigators.
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