Clinical Project Manager
Our clients offer good internal career progression opportunity.
Teamwork spirit and open minded communication style.
About Our Client
Our client is a global top pharmaceutical company that's focusing on new drugs development globally. They've got strong pipeline and great team to support across all functions.
1. Act as local subject matter experts on all operational aspects of local sponsored studies, IIT, MAP and non-interventional trials. As such, contribute to ensure blab la to global SOP and insure local SOP are aligned as appropriate.
2. Manage local sponsored clinical trials including EAP, Compassionate Use MAP and non-interventional studies. Collaborate to the writing of clinical protocols and related documents in collaboration with the Oncology Medical Directors / Franchise or Therapeutic area Head / Directors ,: lead the operational part of clinical trial protocol development process; May contribute to the medical/scientific input for the development of trial-related documents; liaise with the CRO to obtain approval from internal review boards when applicable.
3. May Support the medical director/ TA in development of effective working relationship with investigators to optimize scientific quality/innovation of clinical study design, execution, reporting and publication of local trials. Support the TAs Co-lead investigators meetings with Medical Directors and CRO.. Accountable for all internal meetings related to the clinical trial. Develop effective working relationships with internal and external stakeholders.
4. Ensure the successful of the implementation and execution of local and Regional trials ensuring adequate resources are available in the CRO
5. Accountable for planning, executing and monitoring local and Regional trials through all phases of the trial feasibility till CSR and publication
6. For local and Regional trials, ensure all deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance;, report study progress and issues with their resolution; lead trial level interactions with all relevant functions including Drug Supply Management and CROs
The Successful Applicant
* Education in a health care or scientific discipline is required. At least 3- 5 years CRA experience or 2 year CRO management experience is preferable.
* Fluent English (oral and written)
* More than 5 years of technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
* Proven ability to work independently, as well as ability to collaborate and work effectively in teams. Ability to lead a multidisciplinary trial team in a complex matrix environment and build effective relationship with stakeholders
* Demonstrate effective Project Management skills as well as ability to prioritize based on business need
* Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required. Experience with complex or randomized studies
* Working knowledge hematology/oncology/endocrinology knowledge of therapeutic area is preferred.
* Experience developing effective relationships with investigators.
What's on Offer
Our clients offer a complete in-house supporting team as well as necessary outsourcing partners