Highlights
Leads cross-functional collaboration with Medical Affairs, Clinical Operations, Research & Development, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, Clinical Business Operations, and other relevant functions to support successful study execution. Serves as a subject matter expert for IIS , Collaborative Research, and Expanded Access operational processes and provides guidance, knowledge sharing, and mentorship to team members and cross-functional stakeholders, as appropriate.
Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $52.30–$57.54 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: Senior Clinical Project Manager
Location: Marlborough, MA / Remote
Duration: 08 Months of contract
Job Description
SCOPE:
Responsible for oversight of Investigator Initiated Studies (IIS), Collaborative Research and Expanded Access Programs.
KEY RESPONSIBILITIES:
Location: Marlborough, MA / Remote
Duration: 08 Months of contract
Job Description
SCOPE:
Responsible for oversight of Investigator Initiated Studies (IIS), Collaborative Research and Expanded Access Programs.
KEY RESPONSIBILITIES:
- Provides operational oversight of the Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Program (EAP) portfolio, including study planning, execution, monitoring, and closeout.
- Leads cross-functional collaboration with Medical Affairs, Clinical Operations, Research & Development, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, Clinical Business Operations, and other relevant functions to support successful study execution.
- Serves as a key operational point of contact for investigators and external research partners and establishes collaborative and productive relationships with internal stakeholders, the parent company, and relevant affiliates.
- Monitors study progress, including milestones, patient enrollment, timelines, study drug accountability, contractual obligations, and deliverables.
- Identifies and anticipates potential study risks and operational issues, develops mitigation and contingency plans with minimal oversight, and escalates significant issues or cross-functional misalignment to management as appropriate.
- Drives cross-functional alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps.
- Partners with Clinical Supply and cross-functional stakeholders to assess enrollment projections, study drug requirements, supply availability, expiration considerations, and potential supply risks.
- Collaborates with Clinical Business Operations, Finance, Legal, and investigators to negotiate and finalize Clinical Trial Agreements and study budgets, as applicable.
- Monitors study budgets and tracks contractual milestones, deliverables, payments, and other financial obligations, supporting resolution of budget, invoicing, and payment-related issues as needed.
- Prepares and reviews study-related documents and correspondence, as applicable, and ensures
- required documentation is appropriately maintained and retained.
- Participates in Study Team Meetings, Investigator Meetings, and other study-related meetings, as
- appropriate.
- Prepares and delivers portfolio and study updates to Medical Affairs, cross-functional
- stakeholders, and leadership.
- Confirms completion of study deliverables in accordance with contractual requirements.
- Coordinates receipt and internal review of manuscripts, abstracts, presentations, and other
- scientific deliverables from investigators, including review for applicable legal, intellectual
- property, and safety considerations.
- Supports CyberGrants Portal submissions and serves as backup to the Administrator.
- Ensures assigned studies adhere to applicable regulations, internal requirements, contractual
- obligations, and procedures and provides study-specific subject matter expertise and
- documentation support during regulatory inspections or audits, as applicable.
- Leads or contributes to the development, review, implementation, and continuous improvement
- of SOPs, processes, tools, templates, and workflows supporting IIS, Collaborative Research, and
- Expanded Access activities, including training on applicable procedures.
- Maintains knowledge of the oncology therapeutic area, current medical practices, and applicable
- pharmaceutical regulations to support best practices across activities.
- Serves as a subject matter expert for IIS, Collaborative Research, and Expanded Access
- operational processes and provides guidance, knowledge sharing, and mentorship to team
- members and cross-functional stakeholders, as appropriate.
- Performs other duties and responsibilities as requested by senior management.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS:
- 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.
- BS./M.S./Ph.D. in a related life science discipline is preferred.
- Thorough understanding of the oncology arena.
- Minimum of 3-5 years of industry experience in clinical drug or program development or
- equivalent academic experience in clinical trials.
- 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.
Duties:
- Provides operational oversight of the Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Program (EAP) portfolio, including study planning, execution, monitoring, and closeout.
- Leads cross-functional collaboration with Medical Affairs, Clinical Operations, Research & Development, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, Clinical Business Operations, and other relevant functions to support successful study execution.
- Serves as a key operational point of contact for investigators and external research partners and establishes collaborative and productive relationships with internal stakeholders, the parent company, and relevant affiliates.
- Monitors study progress, including milestones, patient enrollment, timelines, study drug accountability, contractual obligations, and deliverables.
- Identifies and anticipates potential study risks and operational issues, develops mitigation and contingency plans with minimal oversight, and escalates significant issues or cross-functional misalignment to management as appropriate.
- Drives cross-functional alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps.
- Partners with Clinical Supply and cross-functional stakeholders to assess enrollment projections, study drug requirements, supply availability, expiration considerations, and potential supply risks.
- Collaborates with Clinical Business Operations, Finance, Legal, and investigators to negotiate and finalize Clinical Trial Agreements and study budgets, as applicable.
- Monitors study budgets and tracks contractual milestones, deliverables, payments, and other financial obligations, supporting resolution of budget, invoicing, and payment-related issues as needed.
- Prepares and reviews study-related documents and correspondence, as applicable, and ensures required documentation is appropriately maintained and retained.
- Participates in Study Team Meetings, Investigator Meetings, and other study-related meetings, as appropriate.
- Prepares and delivers portfolio and study updates to Medical Affairs, cross-functional stakeholders, and leadership.
- Confirms completion of study deliverables in accordance with contractual requirements.
- Coordinates receipt and internal review of manuscripts, abstracts, presentations, and other scientific deliverables from investigators, including review for applicable legal, intellectual property, and safety considerations.
- Supports CyberGrants Portal submissions and serves as backup to the Administrator.
- Ensures assigned studies adhere to applicable regulations, internal requirements, contractual obligations, and procedures and provides study-specific subject matter expertise and documentation support during regulatory inspections or audits, as applicable.
- Leads or contributes to the development, review, implementation, and continuous improvement of SOPs, processes, tools, templates, and workflows supporting IIS, Collaborative Research, and Expanded Access activities, including training on applicable procedures.
- Maintains knowledge of the oncology therapeutic area, current medical practices, and applicable pharmaceutical regulations to support best practices across activities.
- Serves as a subject matter expert for IIS , Collaborative Research, and Expanded Access operational processes and provides guidance, knowledge sharing, and mentorship to team members and cross-functional stakeholders, as appropriate.
Performs other duties and responsibilities as requested by senior management.
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.
- BS./M.S./Ph.D. in a related life science discipline is preferred.
- Thorough understanding of the oncology arena.
- Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
- 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.
Education:
- Bachelor's degree science/healthcare/business required, advanced degree preferred (PharmD, PhD, MS)
- Minimum 5+ years of industry-based experience in Medical Excellence, operating as a Field MSL, and/or Medical Affairs operations related to biopharmaceutical functions.
Compensation:
The hourly rate for this position is between $52.30-57.54 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Sharath Babu: sharath.b@sunrisesys.com| (732) 395-4575 | URL: www.sunrisesys.com
The hourly rate for this position is between $52.30-57.54 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Sharath Babu: sharath.b@sunrisesys.com| (732) 395-4575 | URL: www.sunrisesys.com
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.