Mount Sinai Careers
ASSOCIATE DIRECTOR PROJECT MANAGMENT - ICAHN INSTITUTE CENTER FOR DIGITAL HEALTH
Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Operating independently, under guidance of the Vice President of Product, Center for Digital Health (CDH), this position will manage clinical projects and / or support collaborations. The incumbent will be responsible for supporting the development and execution of clinical operations strategies in collaboration with key team members.
- Able to independently manage clinical projects and operations within CDH and the clinical study center level.
- Develop project and clinical trial specific milestones and deliverables; prepare reports that summarize key study progress and site-specific issues.
- Prepare clinical and Institutional Review Board documents including subject recruitment documentation.
- Presentations to management and third-party sponsors.
- Recruit clinical research coordinators (CRC) as needed for given studies.
- Guide CRCs through the effective execution of clinical site operations; this includes ensuring clinical trial documentation are fully developed, clinical protocols and site agreements are agreed upon and adhered to, communications within and external to the team are effective, and approved team resources and budgets are appropriately planned and managed.
- Ensure clinical data are accurately reported in databases and applicable site documentation, including but not limited to information used to to create clinical site monitoring and management plans and study protocols.
- Apply learnings from assignments on prior trials to effectively guide teams in operationalizing clinical protocols. Develop and implement risk mitigation strategies to assure that the site and subject enrollment is achieved according to plan.
- Ensure that the clinical site personnel have clear direction on the daily operations required to effectively execute the study; facilitate meetings and clearly communicate decisions and action items to site personnel and relevant parties outside of the team.
- Monitor team dynamics regularly to ensure optimal team performance Ensure all staffing requirements and allotment of available resources to various phases of the study are met.
- Manage the performance evaluation of the CRCs associated with the trial and may evaluate vendors and consultants and their effectiveness and ability to deliver as promised.
- Take action to correct problems and deploy risk mitigation strategies relevant to study execution.
- Resolve conflicts and issues within the CRC team and clinical site personnel.
- Develop clinical subject/volunteer recruitment strategies and monitor study enrollment to ensure that the study personnel are adhering to the clinical protocol.
- Provide significant input into the evaluation and revision of the clinical operations processes and develop tools and process flow maps to facilitate the study design and implementation.
- Participate in clinical site recruitment and liaise with the study personnel including clinical investigators to assure compliance with the study protocol and informed consent form.
- Liaise with the study site personnel to implement efficiencies for trial management and execution.
- BS/MS/PhD with significant healthcare/pharmaceutical/ biotech industry or academic experience (5-10 years preferred)
- Clinical research experience within pharmaceutical companies, hospitals, research facilities, or other healthcare companies. Demonstrated ability to work effectively and accomplish goals in team settings; 5+ years of clinical operations or related experience is preferred
- Effective interpersonal skills; able to establish good working relationships and collaborate with networks of employees of all levels; able to foster cooperation in others; creative problem-solver. Experience in leading teams, committees, or task forces is preferred
- Effective written and oral communication skills
- Knows when and how to speak up and appropriately raise issues to the team and management
- Keeps team members, departmental colleagues (as appropriate) and management fully apprised of project / initiative status and issues
- Demonstrated leadership and credibility: diplomatic, decisive, straightforward, honest
- Ability to delegate work effectively and hold others accountable for deliverables.
- Understanding of HIPAA compliance and applicable clinical site regulations.
- Clinical Trial Management training and / or coursework & training in Clinical Trial Management is plus
- Experience with clinical trial management in Digital Health from mobile health (mHealth), health information technology (HIT), wearable devices, telehealth and telemedicine, and personalized medicine, is a plus
- Project Management Institute (PMI) certification and/or Six Sigma is a plus