Senior Manager, Clinical Project Management

Company: Greenwich Biosciences, Inc.
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Senior Manager, Clinical Project Management UK - Field Based - Cambridge US - Field Based - CA We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results. About the role The Sr. leader serves as a key member of the clinical operations project management core team with the goal to lead the CPM team to ensure efficient oversight and execution of clinical studies. Responsible for providing operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. Overall management of sponsored clinical trials from study design to clinical report finalization, ensuring through expert oversight that the studies are conducted to the highest quality standards, are within the agreed budget and are delivered on time. Responsibilities Provide expert operational oversight and guidance to support prioritization of study activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others Provide management and oversight of sponsored clinical trials in various indications as determined by the needs of the organization. To include overseeing CROs (efficient oversight of KPIs, KRIs, issue management and escalation, 3rd party vendors, contracts, etc.) and to ensure compliance with all regulatory requirements for the study and evaluating and selecting study investigators Line management of clinical project managers, responsibilities including administrative oversight, professional development, and performance appraisals. May be involved in assignment of project work and will review workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level Responsible for ensuring effective team use, full compliance and utilization of Clinical Trial Management Systems (CTMS), eTMF and EDC to ensure best practice study management and efficient use of systems and resources to enable timely study execution and delivery Manage liaison and oversight with CROs and other external vendors to facilitate their ability to complete trials within timelines and to the required quality. This includes training key external staff on trial requirements throughout the trail duration Develop productive working relationships with internal colleagues, investigational site staff and CRO/vendor personnel to ensure high quality reporting throughout all study teams Ensure that the study is conducted in accordance with agreed upon timelines Work closely with internal key stakeholders to ensure successful design, implementation and oversight of clinical trials Take strategic responsibility for process improvement activities in project management and elsewhere in the business. Lead or sponsor process improvement initiatives Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable Ensure the critical internal stakeholders e.g., Biometrics, Pharmacovigilance, Clinical Trials Supplies, Regulatory, Clinical Co-ordination, Data Management are fully informed of study requirements and are able to contribute as required to the trial programme Ensure excellent communication flow between the CRO to the GW internal team Manage financial budgets and timelines for clinical trials Define and manage project resource needs and establish contingency plans for key resources Understand the scope of study contract and impact of change orders on the conduct of the study to meet timelines and budget Participate in the evaluation and selection of Clinical Research Organisations (CROs) and required external vendors (e.g. contract labs, IVRS provider) Ensure appropriate training is provided for the internal teams to conduct the trials Ensure clinical trials are run in accordance with SOP's and relevant regulatory guidelines Maintain good working relationships with key opinion leaders Organise and participate in Investigator Meetings, presenting trial data and training clinical staff Attend relevant International Symposia and keep up to date with significant new research findings appropriate to the therapy area Participate in the development and review of SOPs pertaining to clinical activities Provide regular status reports to Senior Management and Project Team Assist in recruiting new staff, including participation in interview process and new hire on boarding Requirements Degree (BSc or equivalent) Broad Clinical Trial experience Extensive clinical project management experience Extensive experience in CRO oversight and managing outsourced clinical trials A global view of drug development Ability to lead, direct, manage and develop others. Knowledge of relevant SOP's, ICH/GCP and regulatory guidelines General understanding of budgetary control Organisation skills and prioritization Able to use initiative and problem solve Able to work in a team and as an individual Strong leader and navigating the matrix Join Us! Posted 12 Days Ago Full time R0002131 About Us Why Work at Greenwich Biosciences? GW Pharmaceuticals (GW), along with its U.S. subsidiary Greenwich Biosciences, is a pioneering global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicines over the last 20 years. GW's mission is to transform the lives of seriously ill patients through developing and delivering rigorously tested cannabis-derived pharmaceutical medicines. Our aim is to develop regulatory-approved medicines with documented safety and efficacy profiles that are manufactured to the highest standards. GW's research efforts initially focused on the unmet needs of patients with Multiple Sclerosis (MS), while in recent years the Company has focused on helping children and adults with severe, life-threatening forms of epilepsy. Looking to the future, GW's deep scientific knowledge and extensive body of research is enabling the Company to explore new therapeutic areas, including neurology, oncology, psychiatry and autism spectrum disorders. Since the Company was founded in 1998, more than 6,000 patients have been involved in GW's clinical trials globally. GW has collected more than 80,000 years of human safety data, been featured in more than 80 peer-reviewed publications, and generated high-quality evidence which has appeared in the New England Journal of Medicine and The Lancet. In 2018, TIME magazine named GW one of the 'Top 50 Genius Companies of 2018 That Are Inventing the Future' in recognition of this work. We are looking for talented individuals who are passionate about making a difference in the lives of our patients. Greenwich Biosciences' headquarters are in Carlsbad, CA. Our Parent company GW Pharmaceuticals, PLC, was founded in 1998 and is based in the UK.

Keywords: Greenwich Biosciences, Inc., Cambridge , Senior Manager, Clinical Project Management, Healthcare , Cambridge, Massachusetts