Senior Clinical Trial Manager/Clinical Trial Manager - Homebased
Company: Precision For Medicine
Location: Baltimore
Posted on: May 16, 2022
Job Description:
We are a team of clinical trial experts who are dedicated to the
success of our clients so that patients can receive much-needed
treatments. From the beginning, we have nurtured a culture where
patients' needs and the needs of our valued clients come first,
where the quality of our work is the best, and where our employees
can thrive while still having fun and giving back to the patient
community. We are very proud of the Clinical Trial Management team
at Precision for Medicine and what it has achieved thus far. Are
you ready to be part of a close-knit clinical trial team that is
passionate about saving and improving the lives of patients every
single day? Then look no further, we'd like to help you take your
career to the next level.
You will lead and manage the clinical team on a study in regards to
timeline adherence and project scope while ensuring quality
delivery. We encourage high-energy, dedicated professionals who
enjoy a challenge, thrive in the details, and flourish in dynamic
environments to explore this opportunity. If you are no stranger to
taking charge and seek positive partnerships to deliver phenomenal
work, we have an opportunity for you.
About You
- You have a passion for bringing lifesaving and lifealtering
treatments to market
- You love having responsibility and a say in how clinical trials
are run
- You plan ahead but have alternative options in case things go
wrong
- Last minute requests and shifting priorities don't rattle
you
- You are extraordinary at handling study timelines while never
sacrificing quality
- You communicate clearly, often, and concisely and know that
your role is crucial in keeping the trial running smoothly
- You are a master at identifying any risks that threaten
projects and handle them resolutely
- You thrive with minimal direction and happily take
responsibility for the outcomes of your work
- You are a team player and thrive working in a collaborative
environment
About The CTM Role
- Management and operational delivery of the clinical elements
within a trial, including site feasibility and selection, start-up,
clinical plans and document development, subject enrollment, site
engagement and support, monitoring planning and execution,
resourcing, regulatory documentation, data cleaning activities, and
close-out
- Successful execution of assigned trials and ensuring completion
of trial deliverables
- Ensuring appropriate communication and ongoing oversight of
assigned trial(s) by working in close collaboration with the
sponsor and other functional team members
- Participation in and presentation at sponsor meetings,
including bid defenses, kick-off meetings, investigator meetings,
and face-to-face meetings
- Mentoring and training team members
- Identifying challenges to study timelines/deliverables and
offering creative action plans to the team/sponsor
- Leading CRAs as they establish relationships with their sites
for high quality oversight of monitoring, regulatory, IP, and
overall site correspondence activities
- Contribute to company and department initiatives to grow and
strengthen processes, procedures, and the PFM overall
Qualifications
Minimum Required:
- Bachelor's degree or equivalent combination of
education/experience in science or health-related field
- Clinical Trial Lead/Manager: Minimum of 5 years of clinical
research experience or proven competencies for the position with
significant clinical monitoring experience. Prefer at least 2 years
of CTM experience at a CRO, Pharma or Biotech company.
- Senior Clinical Trial Lead/Manager: Minimum of 7 years of
clinical research experience or proven competencies for the
position with significant clinical monitoring experience. Prefer at
least 4 years of CTM experience at a CRO, Pharma or Biotech
company.
Other Required
- Moderate independent field monitoring experience
- Clinical team lead or comparable supervisory experience
- Experience with Microsoft Office Products (Outlook, Word,
Excel, PowerPoint)
- Experience with various EDC and eTMF systems
- Excellent communication and interpersonal skills to effectively
interface with others in a team setting
- Excellent organizational skills, attention to detail, and a
customer service demeanor
- Availability for domestic and international travel, including
overnight stays
Skills
- Demonstrated computer skills (MS Office, M PowerPoint, etc.)
and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.)
- Demonstrated ability to develop positive working relationships
with internal and external organizations
- Demonstrated core understanding of pertientent and various
therapeutic areas, medical terminology, and clinical trial
activities as it relates to the execution of a clinical development
plan
Including, But Not Limited To
Competencies:
- Demonstrates mastery knowledge of ICH-GCP, and regulatory
guidance, as well as the ability to implement
- Working knowledge of clinical management techniques and
tools
- Ability to create an environment where employees have a sense
of ownership that will lead to increases in productivity and
efficiency
- Results-oriented, accountable, motivated, and flexible
- Excellent time management, negotiation, critical thinking,
decision making, analytical, and interpersonal skills
- Direct work experience in a cross-functional environment
- Excellent presentation, verbal, and written communications
skills
- In-depth proven experience in pharmaceutical and/or device
research required
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision For Medicine, Baltimore , Senior Clinical Trial Manager/Clinical Trial Manager - Homebased, Executive , Baltimore, Maryland
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