Responsibilities:
1. Maintain and facilitate interactions with internal functions including but not limited to Medical, Data Management, Biostatistics, Procurement, Regulatory, Pharmacovigilance and Quality Assurance, and external functions including the CROs, partners and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
2. Accountable for all activities of site related study (including feasibility) execution of assigned studies / Monitors involving start-up, execution, and close-out.
3. Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.
4. Ensure adherence to applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Legend Standard Operating Procedures (SOPs), Study Plans and Guidelines, and to quality standards in conducting clinical research.
5. Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.
6. Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with Legend research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
7. Responsible for identifying project specific training needs and standardizing and facilitating training solutions for monitors.
8. May participate in clinical operations quality or process initiatives.
9. Assist in the creation of Standard Operating Procedures.
10.Additional responsibilities as required.
Qualifications:
1. Master degree in medicine, pharmacy or bio-technology.
2. At least 3 years clinical site management experience in pharmaceutical industry/CRO.
3. At least 1 year clinical project management experience is preferred .
4. Thorough knowledge on clinical trial regulatory requirements.
5. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
6. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
7. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading projects with competing deadlines.
8. Drives continuous improvement and simplicity in process and approach and enhances agility.
9. Demonstrated business ethics and integrity.