Lead Clinical Research Associate Resume Example

Preparing, maintaining and implementing action plans Mitigation and contingency plans Ensure cross-functional awareness and buy-in to the risk/opportunities action plans Influence Strategy and Ensure Operational Alignment Lead or contribute to Development of Strategic Clinical Operations Plan Translate development plan goals into tangible relevant goals for studies Partner with PMs and study team members to develop study level plans and goals and ensure alignment with overall development plan. Propose alternative study operation strategies to optimize use of time cost and resource Maintain and enhance knowledge in disease and technical areas and in global regulations/guidelines pertaining to clinical trials Manage Information & Communications Provide high quality study information to support decision making Ensure effective communication across study teams, removing barriers when necessary Ensure study team and stakeholders and informed of progress against goals, major study risks/opportunities and corresponding contingency/mitigation plans Ensure issue escalation and appropriate resolution Demonstrated knowledge of clinical development and regulatory submission processes and requirements Demonstrated ability to manage complex projects and processes Proven track record of effective project management of drug development or other projects in a highly matrixed environment. Required to deliver, time, and cost, quality and risk management to teams. Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget Makes strategic use of business data to monitor & raise performance Provides timely feedback to individuals/supervisors regarding performance Utilizes and encourages and shares innovative approaches to build and maintain a competitive advantage Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards Develops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance Responds to changing situations and others' ideas that differ from own positively and constructively Develops and implements short-term and mid-term goals and project plans to achieve goals based on higher level business drivers and strategies; eliminates obstacles to success Analyzes and solves problems to make effective decisions Consistently takes and encourages actions that are new, or that improve existing approaches and systems Having the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken. Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for others Lobbies key internal and external stakeholders to ensure success Looks for opportunities for collaboration and acts upon them Work with others to ensure close collaboration and support Works collaboratively with group members and contributes to positive intra- and inter-team relationships Demonstrated ability to manage a variety of personnel in a highly matrixed environment. Transparent skills in providing vision, direction and leadership to a group of individuals Drives and encourages conversations and proposals within Teams and between Lines that provide options to deliver the key decision points faster and more cost effectively with respect to the execution of the plan (e.g. pushing the limits of team effectiveness).