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POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Overview

Reporting to the Director of Data Management, the Data Manager will lead activities related to the design, documentation, testing, implementation, and cleaning of clinical data for assigned studies.

Objectives

• Leads and coordinates the data management activities of internal teams and vendors, including the design and implementation of clinical databases and other data collection systems, in coordination with cross-functional team members, as applicable.
• Leads development of case report form standards for oncology studies.
• Assists with identifying and reporting clinical study metrics: including visit/page status, query metrics and data entry backlog, and data outliers and trends, in a consistent manner.
• Oversees DM related vendor activities for assigned projects, ensuring proper quality oversight and delivery within budget.
• Develops and/or reviews study documentation including data management plans, eCRF completion guidelines, coding guidelines, data transfer plans, etc.
• Provides review and input during protocol development, ensuring consistency with schedule of events and protocol text, and clarifying ambiguous or unclear information.
• May review, and propose a strategy to resolve, data issues.
• May be responsible for projects that have been outsourced to contract research organizations, as well as internal projects.
• Reviews and provides input for vendor agreements and facilitates testing prior to first production transfer.
• Escalates issues to mitigate out of scope work or delays in timelines.
• Ensures activities related to medical coding, and reconciliation (e.g., SAE/AESI, lab, imaging, etc.) on assigned studies are conducted, reviewed and approved per study requirements.
• Supports other clinical development functional areas, as applicable.

Accountabilities

• Manages vendor relationships with professionalism and transparency
• Develops maintains, or reviews and approves, the study specific Data Management Project Plan, eCRF Completion Guidelines, Data Transfer Plan, Coding Guidelines, and documents deviations from the Plans with proper remediation and follow-up
• Primary study contact for day-to-day data management activities and is responsible for/oversees all data management deliverables and risk escalation for assigned projects.
• Primary contact for communication, escalation and discussion of topics related to data management timelines and deliverables; request for out-of-scope tasks; and technical or procedural issues. Escalates issues in timely manner and as appropriate to the Director of Data Management.
• Assists with planning and implementing data management timelines and deliverables; responsible for, or ensures DM CRO is, providing database and data management activity status reports, and contributes to the overall project planning, progress tracking and reporting.
• Assists with the generation of project Change Order Amendments and is responsible for ensuring tasks are completed within budget, or identifying a risk to the budget, as it relates to the Data Management function.
• Participate in project kick-off meeting, investigators meeting, and regular project management team meetings.
• Provide support for vendor audits and regulatory inspections. With support, follows up on findings and collaborates for any required remediation.
• Manages the database design process. Oversees EDC User Acceptance Testing (UAT) and/or performs QC related to critical CRFs and variables.
• Manages the process of post-production database changes due to protocol amendments, identified issues or other study needs.
• Reviews key EDC data, data issues and queries, as applicable. May assist site personnel with resolving queries, if needed.
• Oversees and/or performs AE/Serious Adverse Event reconciliation and other reconciliation with 3rd party vendors.
• May assist in resolving medical coding issues related to inaccurate or inconsistent coding of terms. .
• Manages/oversees database soft-lock and hard lock activities.
• Ensure study TMF is inspection ready for assigned studies

Requirements

• BA/BS in scientific field of study

• 7+ years of relevant working experience in the pharmaceutical/biotechnology industry in Phase 1 through Phase 3 studies. 2+ years leading trials is preferred.
• Oncology clinical research experience required, Radiopharmaceutical research a plus
• Experience with reporting software such as Business Objects, j-review, etc.
• Working knowledge of FDA Code of Federal Regulations GCP and ICH Guidelines, CDISC standards and the ability to interpret and apply these guidelines to data management
• Experience with a Regulatory Authority inspection or other audit experience a plus

Competencies

• Inherent drive to cultivate collaboration, teamwork, and professionalism
• Patient Focused and ethical: adopting patient perspective in all interactions
• Ability to work independently and escalate issues as appropriate, be an effective study team lead, and an engaged team member in a dynamic, fast-paced environment
• Nimble, creative, entrepreneurial with the ability to independently execute and/or proactively seek support within own functional area
• Motivated to learn or advance own expertise and value
• Systematically organizing and completing detailed tasks, checking accuracy and completeness of information
• Highly attentive to detail and focused on quality
• Results oriented and able to multi-task

• Able to read, write and speak fluent English with excellent verbal and communication skills

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
• Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume.

Benefits

• Health Care Plan (Medical, Dental & Vision) - effective day 1
• Retirement Plan (401k)
• Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
• Voluntary Income Protection – Premiums paid by employee
• Paid Time Off (Vacation, Sick & Public Holidays)
• $500 fitness reimbursement per year
• $100 cell phone reimbursement per month

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.