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Takeda Pharmaceuticals Sr. Research Manager, Value and Evidence Generation in Helena, Montana

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Job Description

About the Role:

The objective and purpose of the Senior Clinical Research Manager, US Medical Clinical Research, Value and Evidence Generation position is as follows:

  • Partner with Director of Clinical Research Excellence, and Medical Unit as applicable to execute and oversee US Medical Clinical Research program studies, including Investigator Initiated and Sponsored Research (IIR), Medical Company Sponsored Studies (MACS) including Clinical and HEOR, and Collaborative Studies (CCR) for multiple therapeutic areas and product programs. Manage study contracts and budgets, study documentation and study master file, approval process, communicate study activities and status to internal stakeholders, including system management (i.e. CTMS, iEnvision).

  • Responsible for supporting IIR, CCR and MACS (Clinical and HEOR), studies within assigned TA in accordance with all applicable internal legal and compliance policies as well as external regional and country specific regulatory guidelines.

  • Represents US Medical Clinical Research, Value and Evidence Generation Group when interfacing and collaborating with internal stakeholders (e.g. GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc) and external investigators to develop and execute US Medical research plans and budgets.

  • May lead special projects according to USM business needs (e.g. external engagement's, process optimizations).

  • You will report to the Director, US Medical Research Process Excellence

How you will contribute:

ACCOUNTABILITIES

  • Assist in execution of the US Medical research strategic and tactical plans for assigned therapeutic areas in collaboration with US Medical Value and Evidence Generation Leadership, Therapeutic Area Medical Directors, Scientific Directors, Clinical Science Lead, as applicable, and oversee allocation of the research budget.

MACS Studies :

  • Create and Manage receipt, processing and meetings required for study concept and protocol submissions. Provide final approval outcome for research committee materials including study concepts, synopsis and protocols, meeting minutes, and team communications.

  • Manage operations and processes of the internal CTMS for studies per Medical SOPs and processes and propose process improvement as needed.

  • Manage implementation of all Clinical Study Manager and external resource activities to ensure Company Sponsored studies are conducted in GCP compliant and quality manner in adherence to all company processes and applicable laws.

  • Manage cross functional Study Execution Team in order to drive Company Sponsored Studies forward to achieve objectives within target timelines and budget.

  • Manage study contracts and finances including budget forecasting, contract execution & management, change order processes and impact, invoicing and accruals.

  • Conduct/Assist with fair-market value (FMV) assessments of approved studies for assigned therapeutic area in accordance with Takeda policies and procedures using experience from past studies.

  • Participate in SOP development and review to ensure US Medical has current processes relevant to current work and future developments.

  • Responsible for the tracking and communication of key outputs, performance metrics, and accomplishments related to US Medical external research studies within assigned TA and in applicable systems.

  • Responsible for management, entry, quality control (QC), and validation of key data in applicable systems, per SOP requirements and processes.

  • Interface with key internal and external stakeholders (including US Medical Therapeutic Area Medical Directors, Scientific Associate Directors, Liaisons, external investigators, etc) to resolve and discover root cause for study related issues. Support the overall efficient and compliant functioning of the US Medical Research program within assigned therapeutic area.

Collaborative Studies:

  • Manage receipt, processing and meetings required for study concept/synopsis, protocol development and submissions. Provide final approval for research committee materials including study concepts and protocols, meeting minutes, and team communications.

  • Manage operations and internal processes for studies per Medical SOPs and applicable laws and propose process improvement as needed.

  • Responsible for management, entry, quality control (QC), and validation of key data in applicable Takeda systems, per SOP requirements and processes. Support cross functional medical and research team in order to drive research forward to achieve objectives within target timelines and budget.

  • Support collaborative study contracts and finances including budget forecasting, contract execution & management, change order processes and impact, invoicing and accruals.

  • Conduct fair-market value (FMV) assessments of approved studies for assigned therapeutic area in accordance with Takeda policies and procedures using experience from past studies.

IIR Studies :

  • Responsible for Managing receipt and processing of study submissions for externally sponsored research. Review and work with Medical Research leadership to approve research committee materials including study concepts/synopsis and protocols, meeting minutes, and investigator communications ensuring they are scientifically sound and accurate.

  • Facilitate conduct of cross-functional TA research committee meetings used to review, approve, and track studies, as applicable.

  • Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) from US Medical IIR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.

  • Responsible for management, entry, quality control (QC), and validation of key data in applicable systems, per SOP requirements and processes.

  • Conduct fair-market value (FMV) assessments of approved studies for assigned therapeutic area in accordance with Takeda policies and procedures using experience from past studies.

  • Create and manage IIR program budget including, forecasting, contracting, invoicing, internal and external communication plans related to IIRs in partnership with the Medical Unit,

DIMENSIONS AND ASPECTS

Technical/Functional Expertise

  • Understanding of the pharmaceutical industry and regulations governing medical functions within industry activities and medical regulatory process, including clinical and outcomes research, study design, and good clinical practice.

  • Clinical research and program management experience in working with cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function.

  • Experience managing study budgets.

  • Applied knowledge of performance management systems (e.g., metrics, dashboards, CTMS).

Decision-making and Autonomy

  • Ability to predict issues, anticipate risks and solve problems.

  • Ability to articulate & establish processes to foster cross-functional efficiency or resource scalability

Interaction

  • 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.

  • Demonstrated ability to concisely communicate/prepare presentations for management.

  • Excellent organizational skills.

  • Effective negotiation and positive influencing abilities.

  • Proven ability to work effectively and diplomatically in conflict situations.

Innovation

  • Experience in identifying and supporting opportunities for process imporovement and takes on, as needed, non-project responsibilities, which can include project management to implement new processes and systems.

Complexity

  • Management of multiple tasks of varied complexity to enable successful delivery of multiple and/or complex projects within a single or across therapeutic areas for US Medical.

Minimum Requirements/Qualifications:

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Required:

  • Bachelor's degree required, preferably in a health sciences related field with 5+ years healthcare or pharmaceutical industry experience and 3+ years of clinical research, study management and/or clinical project management.

  • Demonstrated understanding of the legal and regulatory guidelines associated with pharmaceutical industry research and external granting functions and the ability to use knowledge to make sound operational decisions.

  • and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to Takeda.

  • Strong understanding of finance principles and their use in managing study budgets.

  • Advanced Degree in a health related field a plus.

  • Experience collaborating and indirectly managing other individuals with a variety of scientific and non-scientific backgrounds and training.

Leadership Skills & Behaviors:

  • Matrix project leadership required.

  • Proven strategic problem-solving ability and identify appropriate solutions.

  • Solid influencing skills and ability to negotiate in a matrix environment to optimize development and address barriers.

  • Highly effective written and verbal communication skills, including strong presentation skills.

  • Ability to execute business process transformation and implement organizational culture change.

  • Simultaneous management of multiple tasks of varied complexity.

  • Flexibility, tolerance and diplomacy to best manage change and differing opinions.

  • Excellent organizational skills.

  • Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict.

  • Sufficient knowledge of all MS Office tools to effectively capture and communicate project information

  • Fluent in English.

ADDITIONAL INFORMATION

  • Must be able to work at computer for several hours at a time.

  • May travel 10% of time, primarily within US with occasional international travel.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Flexible Work Paths

  • Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Base Salary Range : $130,200.00 to 186,000.00$ , based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq

Base Salary Range :$130,200.00 to 186,000.00$, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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