Senior Clinical Project Manager
Ora · United States · 1 mo ago
RemoteRemoteInformation TechnologyFull-time
We need to output HTML fragment with headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate. Preserve all substantive info.
We need to parse the posting.
Let's extract sections:
- About the role: The description after "The Role:" maybe. Also "What You’ll Do:" maybe responsibilities.
We need to decide sections.
We have content about role description: "Ora’s Senior Clinical Project Managers (Sr. CPM) are critical in driving clinical ophthalmic projects forward utilizing best practices in order to ensure budgets, timelines, and clinical trial requirements are being met on behalf of the sponsor. This role will work independently to manage cross functional project teams as well as overseeing other projects they are not directly managing, as a senior member of the clinical operations team, to provide support to more junior team members. Sr. CPM’s have active involvement in each assigned project in order to meet milestones, resolve issues and/ or conflicts in addition to frequent interactions with the study team including but not limited to clinical trial associates, monitoring, clinical research coordinators, investigators and senior management. They are responsible for creating project plans and provide weekly budget and progress reviews for each study in addition to preparing high-quality reports."
That's about the role.
Then "What You’ll Do:" list of duties.
Then "What We Look For:" includes experience needed, additional skills & attributes, competencies and personal traits (maybe split into Requirements, Qualifications, Skills). Also "What We Offer:" benefits.
We need to map to headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We have no explicit Pay or Schedule info. There's mention of "Travel of up to 15% is required (mainly domestic, overnight)." That's schedule? Not exactly schedule. No explicit pay. So we should not create Pay or Schedule sections because they are not stated.
Benefits: "What We Offer:" includes many benefits: healthcare, PTO, holidays, 401K, adoption/fertility assistance, 16 weeks paid parental leave, life & disability insurance, remote & wellness reimbursement, EAP, career development, global team, impact. Also "Benefit Eligibility:" details.
Thus we can create Benefits section.
Now Requirements: maybe "Experience needed for the Role:" includes Bachelors degree, 7 years clinical trial experience, 3 years CPM experience. Also "Additional Skills & Attributes:" includes ophthalmology experience preferred, understanding of multi-center drug/device trials, experience with Veeva TMF and CTMS, ability to establish relationships, organizational/communication skills, ability to plan, identify risks, anticipate issues, respond strategically, expertise of regulatory requirements and GCP, leadership skills, multitask, problem solving, proficiency with Excel, PowerPoint, vendor management, multi-lingual a plus.
Qualifications: maybe overlapping with Requirements. But we need to decide distinct sections. Could treat Requirements as education/experience, Qualifications as additional skills/attributes, Skills as competencies/personal traits? However the instruction says prefer few substantive sections over many thin ones. We could combine into fewer sections: maybe About the role, Responsibilities, Requirements (including experience, skills, qualifications), Benefits. But we must use headings only when posting has real specific content for it. We could include sections: About the role, Responsibilities, Requirements, Benefits. That's four sections.
But we need to follow the instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says "use
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate. Preserve all substantive info.
We need to parse the posting.
Let's extract sections:
- About the role: The description after "The Role:" maybe. Also "What You’ll Do:" maybe responsibilities.
We need to decide sections.
We have content about role description: "Ora’s Senior Clinical Project Managers (Sr. CPM) are critical in driving clinical ophthalmic projects forward utilizing best practices in order to ensure budgets, timelines, and clinical trial requirements are being met on behalf of the sponsor. This role will work independently to manage cross functional project teams as well as overseeing other projects they are not directly managing, as a senior member of the clinical operations team, to provide support to more junior team members. Sr. CPM’s have active involvement in each assigned project in order to meet milestones, resolve issues and/ or conflicts in addition to frequent interactions with the study team including but not limited to clinical trial associates, monitoring, clinical research coordinators, investigators and senior management. They are responsible for creating project plans and provide weekly budget and progress reviews for each study in addition to preparing high-quality reports."
That's about the role.
Then "What You’ll Do:" list of duties.
Then "What We Look For:" includes experience needed, additional skills & attributes, competencies and personal traits (maybe split into Requirements, Qualifications, Skills). Also "What We Offer:" benefits.
We need to map to headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We have no explicit Pay or Schedule info. There's mention of "Travel of up to 15% is required (mainly domestic, overnight)." That's schedule? Not exactly schedule. No explicit pay. So we should not create Pay or Schedule sections because they are not stated.
Benefits: "What We Offer:" includes many benefits: healthcare, PTO, holidays, 401K, adoption/fertility assistance, 16 weeks paid parental leave, life & disability insurance, remote & wellness reimbursement, EAP, career development, global team, impact. Also "Benefit Eligibility:" details.
Thus we can create Benefits section.
Now Requirements: maybe "Experience needed for the Role:" includes Bachelors degree, 7 years clinical trial experience, 3 years CPM experience. Also "Additional Skills & Attributes:" includes ophthalmology experience preferred, understanding of multi-center drug/device trials, experience with Veeva TMF and CTMS, ability to establish relationships, organizational/communication skills, ability to plan, identify risks, anticipate issues, respond strategically, expertise of regulatory requirements and GCP, leadership skills, multitask, problem solving, proficiency with Excel, PowerPoint, vendor management, multi-lingual a plus.
Qualifications: maybe overlapping with Requirements. But we need to decide distinct sections. Could treat Requirements as education/experience, Qualifications as additional skills/attributes, Skills as competencies/personal traits? However the instruction says prefer few substantive sections over many thin ones. We could combine into fewer sections: maybe About the role, Responsibilities, Requirements (including experience, skills, qualifications), Benefits. But we must use headings only when posting has real specific content for it. We could include sections: About the role, Responsibilities, Requirements, Benefits. That's four sections.
But we need to follow the instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says "use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It gives examples but not mandatory to use all. It says "include a section ONLY when the posting has real, specific content for it". So we can choose subset.
Thus we can have About the role, Responsibilities, Requirements, Benefits.
Now we need to extract content for each.
About the role: The paragraph(s) after "The Role:" maybe up to before "What You’ll Do:".
Responsibilities: The bullet list under "What You’ll Do:" (the long paragraph with many duties). Could also include some duties from later like "May manage department Clinical Project Managers..." etc. That's all under "What You’ll Do:".
Requirements: Combine "What We Look For:" subsections: Experience needed for the Role, Additional Skills & Attributes, Competencies and Personal Traits (maybe also "What We Do:" etc). But we need to preserve all substantive info. We'll include all that.
Benefits: "What We Offer:" plus Benefit Eligibility.
We must not include boilerplate like EEO, privacy policy, etc. Remove lines like "People of color, the LGBTQIA+ community..." etc. That's EEO boilerplate; remove. Also remove "Our mission is to weave together..." maybe that's values but could be considered boilerplate? It's part of company description but not specific to job. Might be considered boilerplate; but it's not cookie/navigation/legal/EEO/equal-opportunity/scam-warning. It's more about mission/values. Might be okay to keep? The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The mission statement is not those; but could be considered generic. However it's part of the posting after benefits. Might be considered not specific to role. Safer to remove? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." The mission statement is substantive? It's about company mission, not directly about job. Might be considered boilerplate but not explicitly listed. I'd lean to keep it? But it's not about the role. However the instruction says "Prefer a few substantive sections over many thin ones." Including mission may create thin section. Better to omit.
Thus we will omit the mission/values paragraph after benefits.
Now we need to format lists: Use - for any list of duties/requirements/benefits. For prose use
.
We need to decide what constitutes a list. The responsibilities are a series of sentences separated by periods; could be turned into list items. The posting uses sentences separated by spaces. We'll convert each duty into
- . Similarly for requirements: we can break into items.
We need to ensure we don't lose any detail.
Let's extract responsibilities text:
"What You’ll Do: May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff. Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs. Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programs. Reviews protocol, source documents and CRFs and tracks them to completion. Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project’s progress. Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study. Reviews study metrics for performance and quality with the team and management. Prepares high-quality reports (financial, project, etc.) for management on program status and issues. Ensures review of clinical electronic Trial Master File (eTMF) for completeness. Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers). May represent Ora at professional meetings or seminars. Participates in preparing new study budgets, proposal documents and participating in bid defenses. Active role in department and company-wide process improvement initiatives. Travel of up to 15% is required (mainly domestic, overnight). Adhere to all aspects of Ora’s quality system. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business."
We need to keep all that.
Now requirements: "What We Look For: Experience needed for the Role: Bachelors’ degree in Life Science with at least 7 years of clinical trial experience. Years of experience may be considered in lieu of educationMinimum of 3 years of clinical project management experience. Additional Skills & Attributes:Ophthalmology experience preferred. Understanding of multi-center drug and/or device trials. Experience with Veeva TMF and CTMS systems. Ability to establish and maintain effective professional relationships with co-workers, managers and clients. Highly effective organizational and communication skills. Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives. Demonstrated expertise of applicable regulatory requirements and GCP. Demonstrated leadership skills and the ability to multitask and to solve problems proactively. Proficiency with Excel, PowerPoint and vendor management. Multi-lingual communication is a plusCompetencies and Personal Traits:What We Do:Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. How We Do It:IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. Why We Do It:Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see."
We need to keep all that. However some parts like "What We Do:" etc are more about company values/competencies. Might be considered part of requirements/qualifications. We'll keep.
Now benefits: "What We Offer: Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. Financial: Competitive salaries along with a 401K plan through Fidelity with company match. Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. Career Development Opportunities: Continued opportunities to grow and develop your career journey. Global Team: Opportunities to work with colleagues across the globe. Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal,
- for any list of duties/requirements/benefits. For prose use
. We need to decide what constitutes a list. The responsibilities are a series of sentences separated by periods; could be turned into list items. The posting uses sentences separated by spaces. We'll convert each duty into
- . Similarly for requirements: we can break into items. We need to ensure we don't lose any detail. Let's extract responsibilities text: "What You’ll Do: May manage department Clinical Project Managers, Assistant Project Managers, Clinical Trial Associates and other supporting staff. Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs. Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programs. Reviews protocol, source documents and CRFs and tracks them to completion. Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project’s progress. Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study. Reviews study metrics for performance and quality with the team and management. Prepares high-quality reports (financial, project, etc.) for management on program status and issues. Ensures review of clinical electronic Trial Master File (eTMF) for completeness. Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers). May represent Ora at professional meetings or seminars. Participates in preparing new study budgets, proposal documents and participating in bid defenses. Active role in department and company-wide process improvement initiatives. Travel of up to 15% is required (mainly domestic, overnight). Adhere to all aspects of Ora’s quality system. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business." We need to keep all that. Now requirements: "What We Look For: Experience needed for the Role: Bachelors’ degree in Life Science with at least 7 years of clinical trial experience. Years of experience may be considered in lieu of educationMinimum of 3 years of clinical project management experience. Additional Skills & Attributes:Ophthalmology experience preferred. Understanding of multi-center drug and/or device trials. Experience with Veeva TMF and CTMS systems. Ability to establish and maintain effective professional relationships with co-workers, managers and clients. Highly effective organizational and communication skills. Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives. Demonstrated expertise of applicable regulatory requirements and GCP. Demonstrated leadership skills and the ability to multitask and to solve problems proactively. Proficiency with Excel, PowerPoint and vendor management. Multi-lingual communication is a plusCompetencies and Personal Traits:What We Do:Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. How We Do It:IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. Why We Do It:Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see." We need to keep all that. However some parts like "What We Do:" etc are more about company values/competencies. Might be considered part of requirements/qualifications. We'll keep. Now benefits: "What We Offer: Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. Financial: Competitive salaries along with a 401K plan through Fidelity with company match. Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. Career Development Opportunities: Continued opportunities to grow and develop your career journey. Global Team: Opportunities to work with colleagues across the globe. Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal,