Senior Clinical Program Manager
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Clinical Project Manager, in Stamford, Connecticut. The Senior Clinical Project Manager will partner with various functions within CRD (Clinical Research & Development) Operations to address inefficiencies and identify opportunities for improvements to processes, resources, methods, and technology to achieve quality objectives. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Lead the management and oversight of key performance indicators (KPIs) and key quality indicators (KQIs) to measure project success and benefits and CRO or vendor performance
- Define, optimize, and generate metrics reports, tools, dashboards and scorecards to assess operational efficiencies
- Present metric reporting expectations to CROs and collaborate to ensure accurate and timely reporting in support of governance structures and virtual trial oversight models
- Responsible for understanding CRO and vendor scorecards
- Ensure meaningful data collection and effective use of any new tools needed for the analyses of and consistent reporting on various KPIs, KQIs, and metrics
- Define baselines and provides metrics to identify areas and trends that can be used by the clinical teams for future enhancements and continuous improvements
- Support Operational Excellence initiatives by assisting with the development of standards, procedures, training, etc.
- Tracks ROW timelines and requirements to identify and maintain current Global Regulatory start-up timelines and activities for global clinical trials
- Support quality objectives through the development of process training materials and Curriculums
- Rollout of standards and training for internal staff as well as CRO and investigator site personnel
- Support the clinical development strategies and upfront planning
- Support due diligence efforts and early stage planning activities by producing detailed recommendations with high level timeline based on historical and benchmarking data
- Assist in maintaining a library of pre-approved form documents, templates, and adds or revises material
- Provide strategic direction to staff through line management of a team
- Accountable for effective recruitment, induction, talent development and retention of Staff
- Provide ongoing coaching and feedback including formal performance appraisals, development plans and career coaching
- A minimum of 7 years’ experience either with CRO and or Pharma working with an outsourced model
- Must have Phase II and Phase III experience both US and global
- Bachelor’s Degree or equivalent
- Masters’ Degree and PMP certification are a major plus
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.