Associate Manager Strategic Feasibility, Homebased LATAM, IQVIA Biotech
IQVIA Biotech is accepting applications for Associate Manager Strategic Feasibility. Prior work experience in the pre-award feasibility space is required.
The Associate Feasibility Manager is responsible for supporting the coordination and management of the efforts necessary for producing feasibility proposals and reports. In this capacity, this individual is responsible for assuring the Feasibility Associates and Analysts elicit input from and coordinate activities with all the stake holders in the feasibility process including: Proposals, Study Start-Up, Site Identification Services, Regulatory, Medical, IQVIA CORE™, Project Management and Clinical Operations and combining resulting information with IQVIA Biotech’s corporate experience to produce recommendations for country and site strategies. The Associate Feasibility Manager assures the assembly, editing, and review of feasibility proposals and reports, (feasibility proposals are documents that detail the strategy, actions, and the cost of conducting feasibility, and feasibility reports are documents that describe the outcomes of feasibility projects). The Associate Feasibility Manager may also participate in internal and external briefings and presentations of feasibility, when deemed necessary. This position reports directly to the Director of Feasibility in setting priorities for workload and deliverables in the department.
The Associate Feasibility Manager continues to conduct clinical trial feasibility assessments based on Request for Proposals (RFPs).
To conduct ad-hoc research as requested by IQVIA Biotech Clinical Sr. Management.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Directs the activities of feasibility assessment and/or analysts under their direction.
- Identifying and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations.
- Identifying barriers to enrollment in the form of competing clinical trials. Accessing open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs being studied. Determine whether the countries proposed have comparator drug access/reimbursement. As appropriate prepare tabular displays of this information for evaluation by the feasibility stake holder pool.
- Representing IQVIA Biotech’s global or regional expertise by presenting our clinical trial footprint in the indication which may include compiling corporate experience and expertise in specific indication when needed.
- Working with IQVIA Biotech medical experts on the conduct of the trial as well as its acceptance and standard of care in target regions. Incorporate medical review of the protocol and challenges to enrollment and the retention of subjects.
- Collaborating with IQVIA Biotech Regulatory Affairs determine regulatory timelines associated with the conduct of the proposed trial.
- Work with the proposals team to determine costing of conducting a stand-alone feasibility assessment, if applicable.
- Provides overall recommendations on the countries, number of sites and projected number of patients resulting from collaborative discussions noted above designed to meet or exceed client stated goals.
- This function also identifies alternatives to client initial recommendations resulting from information gathered.
- Supports developing increased capacity within the Feasibility Department to assure ability to meet overall Corporate Business Development Goals.
- May be assigned some supervisory or line management responsibilities.
- Provides guidance as needed for completion of tasks. Assesses performance of new team members and communicates assessment to the Associate Director and Director of Feasibility.
- Supports that Feasibility function interfaces effectively with all other key operating departments within IQVIA Biotech.
- Promotes and utilizes the IQVIA CORE™ data sets and resources to define and enhance the strategy.
- Ensures training for the Feasibility Analysts and Associate.
- Reviews and approves reports and manuscripts, as necessary.
- Maintains current knowledge of regulations, and guidelines appropriate for functioning in this capacity.
- Personally, conducts Feasibility activities as described in the Sr. Feasibility Analyst role.
- Maintains detailed records of work and creates and maintains internal libraries and databases, while also remaining informed of current scientific and clinical research being conducted.
- Works closely with members of management team and client to negotiate scope of work to be performed for a project.
- Performs other duties as assigned.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Demonstrated knowledge of government/international databases, open source databases or more proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, Citeline).
- Demonstrated ability to form strong working relationships with other groups within the organization essential to high level performance in this position.
- Demonstrated knowledge of quality assurance related to the Feasibility process and willingness to promote the quality process within the group.
- Ability to motivate, lead, and grow a team.
- Demonstrated knowledge and proficiency of the IQVIA CORE™ data sets, services and resources.
- Experience with pharmaceutical product development.
- Knowledge of FDA and/or ICH-GCP guidelines for conducting clinical research.
- Excellent written and verbal communication skills.
- Strong proficiency of Microsoft Office applications and data queries.
- Exceptional ability to conceptualize, develop and manage timelines.
- Demonstrated knowledge of resources required to permit development of or reporting on results of the feasibility process.
- Considerable ability to develop and maintain productive relationships with colleagues and other research organizations.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties.
- Ability to travel, as needed (domestically or internationally).
MINIMUM RECRUITMENT STANDARDS:
- Bachelor’s Degree in a scientific field (advanced scientific/clinical degree, such as PhD or PharmD, preferred) and at least 2 - 3 years of direct experience in scientific report or manuscript writing; at least two years of relevant/related experience within a CRO setting.
- Two or more years of experience working as a Feasibility Analyst in a pre-award setting for a CRO.
- At least 1 year in a client-facing role, including experience with presenting feasibility analyses in front of clients at bid defenses.
- Demonstrated ability to work effectively at all levels of an organization.
- Demonstrated career progression or advancement.
- Demonstrated consistency of exceeding goals and/or performance expectations as an Analyst 1 or 2 (internal candidates).
- Demonstrated leadership ability.
- Excellent written and verbal communication skills. Prior experience in publishing peer-reviewed publications and giving scientific/clinical research presentations.
- Ability to work independently, prioritize and work in a team environment is essential.
- Working proficiency of Microsoft Word, Excel, and PowerPoint required.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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