Clinical Study Manager
Clinical Study Manager
Job Number: 21-04227
Job Number: 21-04227
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Study Manager for our client in New York, NY.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Pharmaceutical's Global Medical Epidemiology (GME) group conducts research, often using large, external data bases, to generate a better understanding of disease context and medical outcomes and improve medical decision-making.
- The three pillars of GME's remit are: (i) Regulatory Use of Epidemiology Data, (ii) Disease Natural History Studies to inform Clinical Trial Design, and (iii) Epidemiology Data for Quantitative Benefit-Risk Assessment.
- GME's impacts include improving the efficiency and likelihood of success of early phase clinical trials, building more robust benefit-risk profiles to provide a more thorough assessment of new products, and incorporating these insights to support regulatory filings.
- GME's value is based on deeper understanding of disease that improves quality and precision of Pharmaceutical medical decisions.
- The mission of GME is to employ the scientific methods and principles of epidemiology to secure regulatory approval, accelerate clinical development, and build benefit-risk profiles.
- Looking for a collaborative and innovative team member to join GME and contribute to our mission of understanding diseases across all stages of drug development, which accelerates the availability of breakthrough medicines that impact patients' lives.
- The Epidemiology Scientist – Contractor position provides an opportunity for an epidemiologist to play an essential role in advancing the generation of real-world evidence and its application to drug development. This role requires someone with strong technical expertise, analytic ability, creativity and communication skills.
- The Epidemiology Scientist – Contractor will also partner with internal and external stakeholders on the design and conduct of epidemiologic research to inform clinical development programs and to support regulatory submissions to the FDA, EMA and other agencies globally.
- The role will involve internal and external collaborations in conceptualizing and proposing epidemiologic studies, and in writing and reviewing protocols, reports, and presentations.
- Studies will be communicated in writing and in presentations to internal stakeholders, regulatory authorities, medical professionals and others. The incumbent will also develop and adopt innovative pharmacoepidemiologic methodologies and contribute thought leadership internally and externally regarding Pharmaceutical's understanding of disease epidemiology/ pharmacoepidemiology to support decision-making across portfolios.
- Specifically, the contractor will support the Internal medicine, rare disease, and emerging markets therapeutic area epidemiology activities.
- Propose and produce GME deliverables for development and product/asset teams, including:
- Background safety and effectiveness epidemiology studies and disease natural history studies.
- Indicated population cohorts for external control arms and regulatory submission.
- Post-approval effectiveness studies
- Feasibility assessments and identification of fit-for-purpose data for observational research
- Other epidemiology studies (e.g., special subpopulations, new indications)
- Critical assessment and review of epidemiological data and literature
- Design and implement primary or secondary data collection or hybrid design pharmacoepidemiologic studies intended to quantify benefits and/or risks potentially associated with Pharmaceutical products
- Participate in GME peer review of study protocols and reports
- Support multiple product teams on epidemiology related issues
- Work collaboratively with key stakeholders internally (such as Clinical, Medical, Regulatory, Outcomes Research, and Data Scientists) and externally (such as academics, regulators, vendors)
- Provide support of and/or attend FDA Advisory Committee meetings and EMA Oral Explanations and other related interactions and negotiations with regulatory agencies on epidemiologic issues as needed
- Represent GME within the relevant therapeutic areas by advocating its importance and building a network of partners
- Contribute to the continuing education of relevant line functions on the value and impact of epidemiology methods and studies
- Develop and implement strategic communication plans to educate Pharmaceutical stakeholders of the role and remit of GME. Articulate how epidemiology studies can be used to strengthen clinical trial design and facilitate use of accelerated regulatory pathways
- PhD with at least 3 years' experience in Epidemiology or another Quantitative Public Health discipline, or MPH with at least 6 years of the above experience
- Expertise in epidemiology to advise on disease areas, data, technology, and risk management strategies to development projects and marketed products
- Practical experience with implementation of observational or experimental studies
- Ability to discern strengths and limitations of real-world datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing epidemiology study designs
- Ability to prioritize and operate in a fast business environment, while not compromising on scientific quality and rigor
- Change agile and able to manage diverse portfolio of research projects
- Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
- Five or more years experience in the pharmaceutical industry, academia, public health, or other relevant positions following MPH/PHD/MD degree completion, including experience in regulatory interactions regarding clinical or observational research
- Experience in safety signal refinement and evaluation
- Consulting experience in epidemiologic research a plus
- Demonstrated record of peer-reviewed publications
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.