Kelly Services Manager Clinical Research in Cambridge, Massachusetts
Kelly is hiring a Manager Clinical Research for one of our biotech clients in Cambridge, MA.
6 month contract
• Manage operational aspects of assigned GMA related research studies and trials for programs including Medical Affairs Company Sponsored Studies (MACS), the Takeda Investigator Initiated Research (IIR) programs, and Takeda Collaborative Research program (CCR) studies for assigned therapeutic areas and product programs.
• Oversees the tracking of MA studies/programs/projects by working closely with inter-nal/external stakeholders and communication of key outputs, operational/performance metrics, and accomplishments related to GMAO research. Oversees the appropriate disclosure of study related information.
• Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.
• May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators execute research plans and budgets.
• Oversee and/or facilitate receipt, processing, and internal cross-functional review of internal/external programs/projects submissions
• Review and approve program/projects materials .
• Lead required cross-functional review meetings to review, approve, and track pro-grams/projects
• Oversee and/or facilitate the management of the internal electronic tracking systems and document repositories per SOPs
• Oversees and coordinates support for internal and external audits related to the medical affairs programs/projects.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
• Knowledge of pharmaceutical industry and program management
• Knowledge of the drug development and commercialization process and an understanding of the functions within the pharmaceutical industry
• Proven ability to communicate clearly and present key information objectively and collaborate effectively with management
• Knowledge of regulatory and compliance guidelines governing medical affairs
• Therapeutic area expertise is desirable
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
• Project leadership and management skills desirable
• Strategic problem-solving ability
• Strong Influencing skills
• Experience building effective networks with internal stakeholders to achieve project goals
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
• Ability to articulate and establish processes which impact cross-functionally
• Issue identification and independent resolution
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
• Flexibility, tolerance and diplomacy to best manage change and differing opinions
• Ability to work in a highly complex, multi-cultural, often stressful environment
• Highly effective communications skills – written and verbal
• Excellent organizational skills
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
• Experience in identifying opportunities for process improvement and takes on, as needed, non-project responsibilities, which can include project management processes and systems
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
• Management of multiple tasks of varied complexity to enable successful delivery of multiple and/or complex projects
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor’s degree required, preferably in a health sciences related field with 5+ years of re-search related experience and/or pharmaceutical industry experience.
Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.
Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to Takeda.
Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training
Research experience (health sciences related), Pharmaceutical Industry including CRO
Experience working in a global organization highly desirable.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
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