Jobs · Project Management

Clinical Project Manager

Sumitomo Pharma America, Inc. · United States · 1 mo ago
RemoteRemoteProject Management$131k–$164k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, scam warning, duplicated lines, application instructions. We need to parse the posting. Let's extract sections: - About the role: The first paragraph: "Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn." That's about the company, not exactly role but could be "About the role"? Actually "Scope" heading then description: "Scope The Clinical Project Manager is responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly manage outside Clinical Research Organizations." That's about the role. So we can put that under About the role. - Responsibilities: The "Key Responsibilities" list is long bullet-like sentences. We need to put them in
  • . Should we separate into multiple li each sentence. We'll extract each responsibility as separate li. - Professional Experience / Qualifications: This includes education, experience, skills etc. We need to split into Requirements, Qualifications, Skills perhaps. The instruction: Use headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to map content accordingly. We have "Professional Experience / Qualifications:" then list of items: BS or MS in a related life science discipline is preferred. Minimum of 3 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials. Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills. Demonstrated skills working within a matrix environment. Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan. Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance. Thorough understanding of the oncology arena. Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders. Strong attention to detail and the ability to establish priorities, schedule and meet deadlines. Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems. Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas. Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards. Strong analytical skills with a data driven approach to planning, executing, and problem solving. Working knowledge of current global regulatory requirements and guidelines for clinical trials. These could be considered Requirements (experience, education) and Qualifications (skills). But we have separate headings for Requirements, Qualifications, Skills. We need to decide what goes where. Typically Requirements: education, years experience. Qualifications: maybe specific expertise like oncology understanding, regulatory knowledge. Skills: leadership, communication, analytical, etc. But we can distribute. We also have Travel Requirements, Mental/Physical Requirements sections. Those could go under Requirements? Or maybe we create a separate section? Not in list. We could incorporate into Requirements or maybe we skip if not fitting headings. The instruction: include a section ONLY when posting has real specific content for it. So we can include Requirements (education, experience, travel, mental/physical). Qualifications (maybe oncology expertise, regulatory knowledge). Skills (leadership, communication, analytical, etc). Benefits: we have description of base salary range, total rewards package, 401(k), medical, dental, vision, life and disability insurances, time-off policy, holidays, sick time. Pay: base salary range. Schedule: Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed. That's schedule? Actually schedule could be remote vs onsite, travel. We'll put schedule section with that. We must not include boilerplate like Disclaimer, Confidential Data, Compliance, EEO, drug screening, accommodation contact, etc. Also remove duplicated lines. Now craft HTML. Structure:

    About the role

    ... (scope description)

    Responsibilities

    • ...
    • ...

    Requirements

    • BS or MS in a related life science discipline is preferred.
    • Minimum of 3 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
    • Primarily remote role with periodic on-site meetings in office.
    • Must be able to travel domestically and internationally as needed.
    • Fast-paced environment handling multiple demands is involved; must be able to exercise appropriate judgment as necessary; requires a high level of initiative and independence.
    • Excellent written and oral communication skills required.
    • Requires ability to use a personal computer for extended periods of time.
    But note some of those are more like skills. However we can keep.

    Qualifications

    • Thorough understanding of the oncology arena.
    • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders.
    • Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas.
    • Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
    • Working knowledge of current global regulatory requirements and guidelines for clinical trials.

    Skills

    • Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
    • Demonstrated skills working within a matrix environment.
    • Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan.
    • Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
    • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
    • Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
    • Strong analytical skills with a data driven approach to planning, executing, and problem solving.
    • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
    • Ability to provide input as the subject matter expert for the assigned studies during regulatory inspections.
    • Ability to establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
    • Ability to evaluate issues found in clinical studies, communication and oversight of CROs and vendors, and suggest and implement solutions and mitigations as required.
    • Ability to evaluate CRO and vendor performance and support improvement initiatives.
    • Ability to participate in the preparation, review, updating and training of SOPs.
    • Ability to maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
    • May mentor other team members.
    But many of these overlap with responsibilities. However we must preserve all substantive info; we can keep them. But we might be duplicating too much. However instruction: preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include all points from the posting. That includes many items under Professional Experience/Qualifications and also many responsibilities. We need to ensure we don't miss any. Let's list all substantive bullet points from the posting: From "Scope": The Clinical Project Manager is responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly manage outside Clinical Research Organizations. From "Key Responsibilities": each sentence: 1. Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines. 2. Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data. 3. Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company. 4. Provides oversight and management of CROs, consultants and vendors. 5. Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact. 6. Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines. 7. Monitors the status of clinical data collection of assigned clinical trials. 8. Prepares potential investigator site lists and assists with their evaluation for inclusion in the study. 9. Prepares and reviews study-related documents when required. 10. Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies. 11. Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required. 12. Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training. 13. Reviews correspondences and monitoring reports relating to the studies. 14. Prepare and deliver program/study updates. 15. Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members. 16. Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team. 17. Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable). 18. Provides input into contracts, work orders and/or change orders. 19. Manages escalation of study related issues and communicates as appropriate with management and other R&D functions. 20. Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight. 21. Ensures assigned studies adhere to all applicable regulations and requirements. 22. Provides input as the subject matter expert for the assigned studies during regulatory inspections. 23. Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates. 24. Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required. 25. Evaluate CRO and vendor performance and support the improvement initiatives. 26. Participate in the preparation, review, updating and training of SOPs. 27. Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities. 28. May Mentor other team members. 29. Perform other duties as requested by the senior management. Now "Professional Experience / Qualifications:" list: - BS or MS in a related life science discipline is preferred. - Minimum of 3 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials. - Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills. - Demonstrated skills working within a matrix environment. - Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan. - Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance. - Thorough understanding of the oncology arena. - Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders. - Strong attention

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