Clinical Project Manager - Oncology CRO
Location: Raleigh - Work from Home, North Carolina US
Job Id: 6231
Position Title: Project Manager
Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
We provide all essential services needed for the development of novel therapeutics including, clinical development planning, study start up, clinical trial execution, translational sciences and expansive services in biometrics. Our personalized approach to clinical operations combined with the deep science of our translational services provides our clients with efficient delivery from one core team, deeper data and a tailored pathway to accelerated development.
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
As a Project Manager, you will serve as the primary point of contact with the sponsor, providing outstanding customer service. You will oversee all aspects of a clinical research trial including managing project timelines, study budgets, resource plans and defining project/program.
- You like to wear many hats and enjoy rolling up your sleeves to get the job done
- You use your solid interpersonal skills and project management toolbox to proactively anticipate and handle project movements.
- You are proactive and a problem solver, always thinking of every angle and scenario that hasn’t been thought of
- You get passionate about having the empowerment to manage studies and having your voice heard
- You thrive in an open-minded and collaborative environment where ideas are shared and fostered
- You love being tapped by project leadership for your expertise and feedback
Essential Duties (include but are not limited to):
- Oversees and manages all aspects of a clinical research trial
- Prepares and reviews of protocols and other study documentation
- Designs and develops CRF and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
- Leads study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
- Manages site start up procedures including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the project manager
- Conducts all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH-GCP and Precision Oncology’s SOPs
- Performs data management activities, including in-house CRF review, query resolution, and assists data management personnel resolve data discrepancies
- Conducts feasibility work when requested
- Mentors, trains, and supervises staff at a functional level
- Prepares accurate and timely visit reports from all monitoring visits
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
- Establishes tracking metrics to monitor trial and team progress towards project goals
- Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process and when required, may write narratives and follow-up on SAEs
- Negotiates study budgets and assists with the execution of investigator contracts with support from the legal department
- Initiates payment requests for investigators
- Travel up 20% including site visits, quarterly business reviews, kick off meetings and bid defenses
- 4-year college degree or equivalent experience
- 5 years or more in clinical operations, data management or related discipline either in CRO or pharmaceutical industry.
- Direct supervisory or experience managing people is expected in candidates for this position.
- Oncology experience
- Ability to drive and availability for domestic and international travel including overnight stays.
- Graduate or postgraduate degree in a scientific or healthcare discipline
Division: Precision For Medicine
Business Unit: Clinical Solutions
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Country: United States
Community / Marketing Title: Clinical Project Manager - Oncology CRO
State: North Carolina
Country: United States
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Location_formattedLocationLong: Raleigh - Work from Home, North Carolina US