Medical Director
Company: Advanced Clinical
Location: Deerfield
Posted on: May 12, 2022
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Job Description:
*Overview*****This is a work from home position that can be
worked remotely from anywhere in the United States****The Medical
Director is responsible for delivery of medical monitoring
services, including, but not limited to, working with clinical
project teams to monitor the safety of ongoing studies, and support
database locks. The MD will work with the clinical teams to review
the safety data including review of MedWatch/CIOMS forms. This
individual must have the ability to work and communicate
efficiently with internal and external partners. The MD must be a
licensed Medical Doctor (MD) or Doctor of Osteopathy (DO)
preferably with experience in Oncology. A minimum of five (5) years
of industry experience and in depth knowledge of, and experience
as, a medical monitor for clinical trials (Phase I - III) is
necessary. This individual must possess strong verbal and written
communication competencies as well as interpersonal skills with
experience participating on project teams, coordinating safety
activities and adhering to tight timelines. The MD will attend
regularly scheduled meetings as required and respond to site,
sponsor and Health Authority questions. He/she will attend and
present at Investigator meetings, review CRFs, present study
updates as needed, train in-house staff and project teams, design
and implement safety monitoring plans, conduct data base listings
(DBL) final reviews, review blinded tables, listing & figures
(TLFs), review protocol deviations, and participate in all DBL
meetings as assigned. The MM will review final TLFs, work with the
medical writer(s) to review & revise Clinical Study Report (CSR)
documents, review discussion and conclusions, and participate in
comment resolution meetings. The MD may present topline results to
Sponsors or Competent Authorities. Other tasks may be required as
determined by the project. The position is preferably based in the
Chicago, IL, area but working remotely with occasional face to face
meetings is acceptable depending on business needs. He/she will
need to be present in the Deerfield, IL, office for initial
onboarding/training.Advanced Clinical is a global clinical
development organization that provides CRO, FSP, Quality &
Validation, and Strategic Resourcing services for biopharmaceutical
and medical device organizations. Our mission is to deliver a
better clinical experience for our clients. With global experience
in over 50 countries, we are committed to improving all lives
touched by clinical research. We understand the complex nature of
the clinical research industry and approach each opportunity with
compassion. Together, we answer the hopes of patients and
healthcare professionals with industry-leading services in global
life-sciences. As part of the Advanced Group family of companies,
Advanced Clinical employees provide the support, structure, and
professional background and experience for better clinical trials
and research. They are the foundation of our energetic and
collaborative environment, where constant learning and service to
others take top priority. We seek dynamic, hard-working team
members who are inspired to work amongst diverse backgrounds and
perspectives. From our altruistic mission to outstanding career
development opportunities, there's no better place to grow your
career than Advanced Clinical.*Responsibilities*
* Assist with RFP/RFI completion and attend sales meetings as
requested by Business Development* Oversees the management of
medical monitoring during the course of clinical trials and
projects* Oversees medical review of key clinical documents,
individual case safety reports, and medical or safety-related
regulatory documents* Provides support and input into the planning,
design, preparation, initiation, and execution of study protocols
and other required documentation in compliance with project plans,
federal regulations, GCP, and good medical practice. * May
participate in the evaluation and selection of investigators and
study sites as well as analysis of medical activities* Ensures
delivery of medical/clinical direction to investigative sites per
contract deliverables* Prepares medical and safety plans for
clinical trials/services* Oversees collection, review, guidance and
manages overall safety case processing as dictated by client
contracts * Oversees reviews and directs medical and safety
sections of regulatory document submissions* May participate in
Investigator meetings* Develops and assists other staff in the
development of processes, timelines, planning, and strategy*
Facilitates collaboration and communication with medical/scientific
personnel and ensures that the most current research information is
accessible for review*Qualifications*This individual requires an
excellent understanding of the clinical/pharmaceutical process so
as to effectively communicate and create required deliverables*.
*Possesses advanced knowledge of, and ability to, apply ICH GCP and
all applicable FDA and international pharmacovigilance regulations
and guidelines. Possesses exceptional leadership skills and proven
industry vision. Requires effective negotiation and interpersonal
communication skills to interact with a variety of peers and
constituents*. *Must have the ability to understand complex
clinical and statistical data and issues from an analytic
standpoint*. ** Education: Medical Doctor (MD) or Doctor of
Osteopathy (DO) from an accredited university. Specialty in
oncology preferred. * Certification: Preferably board certified in
the US.* Experience: Minimum of five (5) years of clinical research
and medical/safety management experience in the pharmaceutical
industry*At Advanced Group, our commitment to diversity and
inclusion in every part of our organization is crucial to
fulfilling our **mission and demonstrating our REAL values. A
diverse staff allows us to effectively draw on different
perspectives and enhance our efficiency and effectiveness.
Diversity thereby strengthens the legitimacy and relevance of
Advanced Group in delivering ser**vices to our clients. We seek
talented, creative individuals from a variety of backgrounds and
cultures to work with us. It is our priority that our workplace be
inclusive, welcoming of diverse ideas and appreciative of valuable
experience.*Equal Employment OpportunityIt is Advanced Group's
practice not to discriminate against any Employee or applicant
because of sex, race, color, age, national origin, religion,
gender, gender identity or expression, sexual orientation or sexual
preference, pregnancy or maternity, genetic information, marital
status, physical or mental disability, medical condition, military
or veteran status, or any other basis protected by applicable
federal, state, or local law.This practice applies to all terms and
conditions of employment including, but not limited to, hiring,
training, compensation, benefits, promotions, transfers, layoff,
Company-sponsored education, social and recreational programs, and
treatment on the job. If you have a disability or handicap and
would like us to accommodate you in any reasonable way, please
inform your Recruiter so that we can meet to discuss the
appropriate alternatives available.
Keywords: Advanced Clinical, Arlington Heights , Medical Director, Healthcare , Deerfield, Illinois
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