JOB TITLE: Clinical Operation, Senior Manager
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: China Clinical Development
JOB LOCATION: Beijing, China
REPORTS TO: Head of Clinical Operation & Innovation
EFFECTIVE DATE: 3/31/2020 or earlier
SUMMARY: Drives the Clinical Project Management strategy and deliverables by execution of clinical projects or supporting clinical project managers who are responsible for clinical projects execution.
DUTIES AND RESPONSIBILITIES:
Is responsible for or supports the Clinical Project Managers for the overall operational planning and activities for the implementation and conduct of studies in compliance with quality standards including ICH-GCP, local regulations and company SOPs, according to agreed study timeline and budget;
Is involved in the scientific conduct of the studies and acts as the leader of operational disciplines to execute clinical programs from the Extended Synopsis (ES) preparation to the release of the Clinical Study Report (CSR) in close collaboration with others study team members;
Is responsible for or supports the Clinical Project Managers in the development of study management plans including enrollment plan, risk management plan, study budget planning and management plan, communication plan and site monitoring plan in collaboration with strategic partners, actively supports early engagement with strategic partners;
Supports and facilitates clinical project issue resolution and escalation;
Collaborate with the Clinical Supply Operational Manager to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process;
Anticipates project risks and develop and implement risk management plans to minimize negative impact in fulfilling project deliverables. Coordinates real-time inspection readiness for all projects within scope as necessary;
Leverages experience and lessons learned from internal ongoing/completed projects to ensure process improvements are implemented successfully across projects, to ensure the quality of the deliverables;
Supports Head of Clinical Operation & Innovation to set up and maintain internal processes for CO related activities and innovations on CO outsourcing and oversight models;
Supports Head of Clinical Operation & Innovation in internal resource planning and actively provides feedback & constructive suggestions on project managers;
Acts as representative of responsible projects in Leadership meeting;
Bachelor’s degree (advanced degree preferred), life sciences preferred or healthcare-related field;
7 years or above of working experiences of clinical operation or project management in pharmaceutical or biotechnology industry;
Project management experience with solid track record is required;
Good understanding of global and local regulatory guidelines, GCP, Health authority requirements and clinical development process;
Strong interpersonal and communication skills (verbal and written) in Chinese and English;
Ability to handle multiple task and to prioritize, strong organizational and presentation skills;
Leadership skills, decision-making and problem-solving skills
Good cross-functional team leader who fosters team spirit and team motivation (team work)
Experience in managing and leading international meetings and ability to work in an international environment with internal and/or external partners (CROs etc)
Established awareness and respect of cultural differences and competent to collaborate with global partners/vendors;
Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
Leadership--Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Ethics--Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Strategic Thinking--Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
Judgment--Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Initiative--Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation--Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.