Senior Manager, Clinical Project Management
Company: Greenwich Biosciences, Inc.
Location: Cambridge
Posted on: February 25, 2021
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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
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