临床运营经理

Role Description:
The position is accountable for all activities of site relate********execution directly or by leadership of assigne******** involvingstart-up, execut******** an********-out.

Key Responsibilitie********
1.Maintain an******** interactions with internal functions including butnot limite******** Me******** Data Management, Procurement, Regulatory,Patient Safety an******** Assurance, an******** functions including theCROs, partners an******** external service providers to ensure anefficient study delivery to t******** costs an******** objectives.
2.Accountable for all activities of site relate******** (includingfeasibility) execution of assigne******** / Monitors involving start-up,execut******** an********-out.
3.Oversee site evaluation/select******** contrac******** negot********regulatory/EC submissions startup, issue management, relationshipmanagement, mon******** an******** closure. Provide local regulatoryan******** requirement expertise.
4.Ensure adherence to applicable local regulat******** Goo********Practices (GCPs), ICH Gu******** Legen******** Operating Procedures(SOPs), Monitoring Plans, an******** quality standards in conductingclinical research.
5.Ensure audit an******** readiness of assigne********. Advise onpre-audit activities for GCP requirements. Prepare an******** up sitean******** au******** CAPA preparation an********.
6.Accountable for resource management for assigne********. Provideongoing assessment an******** towards resource needs an********allocating resources in alignment with Legen******** goals, pr********an******** study timelines. Proactively identify an******** issuesimpacting resource allocation an******** solutions.
7.Responsible for the acquisition an********, performance management,an******** an******** of talent. May be responsible for being the pointof contact for CROs for an assigne******** / studies. Mayparticipate/lea******** task forces an********.
8.Responsible for identifying training needs an******** an********training solutions for monitors. Provide consistent best practiceapproach to onboar******** consolidating "lessons learned"across areas an******** into monitoring training mater******** definingbest practice training curr******** an******** awareness of upcomingchanges to ensure effective training is delivere******** a timelymanner.
9.Assist in the creation of Standar******** Procedures.
10.Additional responsibilities as required.

Qualification********
1.Master degree in me******** pharmacy or bio-technology
2.At least 3 years clinical site management experience in pharmaceuticalindustry/CRO
3.At least 1 year clinical project management experience is preferred
4.Thorough knowledge on clinical trial regulatory requirements
5.Strong analytical an******** thinking skills to evaluate complexissues from multiple perspectives an******** smart decision making
6.Excellent interpersonal skills with the ability to communicatepersuasively an******** clar******** flexibility an******** to changingre******** resourcefulness an********. Demonstrate******** an********team player
7.Exhibits strong planning an******** skills an******** level offlexibility in a dynamic env******** with experience leading projectswith competing deadlines
8.Drives continuous improvement an******** in process an********an******** agility
9.Demonstrate******** ethics an********
10.Language: Chinese & Business English fluency