Source Job

• Responsible for delivery of site activation readiness within the assigned country/sites.
• Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points.

Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

• Responsible for timely and quality delivery of site activation readiness, mitigating risks.
• Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
• Maintain project plans, trackers, and regulatory intelligence tools.

Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.

• Perform discovery visits to access sites for research partnerships.
• Provide protocol and product/procedural training to clinical sites.
• Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.

• Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
• Identify potential study risks and propose solutions on how to mitigate them.

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.

• Independently oversees study site management, ensuring patient safety and data quality.
• Manages site start-up procedures, including feasibility, regulatory submissions, and document review.
• Conducts site visits, prepares reports, and communicates with site personnel and project management.

Precision for Medicine integrates new technologies, expertise, and operational scale to improve the speed, cost, and success rate of life-changing therapies. They integrate clinical trial execution with scientific knowledge, lab expertise, and data sciences with a focus on Oncology and Rare Disease.

• Facilitate team alignment by running meetings, coordinating agendas, and driving accountability.
• Enable communication and change management across teams through overseeing communication mechanisms.
• Lead research program management by overseeing timelines and deliverables for research projects.

Omada Health is dedicated to inspiring and engaging individuals in lifelong health improvement. They address lifestyle and behavior changes for those managing chronic conditions, using a multi-condition platform and connected devices to deliver personalized care.

• Considered as the primary point of contact for the investigative site and strengthens AbbVie’s positioning.
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision.
• Develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment.

AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues. They strive to have a remarkable impact on people's lives across several key therapeutic areas.

• Assist with investigator recruitment activities and site feasibility tasks.
• Perform essential document collection, review, and maintenance activities.
• Act as site contact for study and site management issues.

Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.

• Facilitating negotiations of site agreements and budgets to ensure alignment with the site activation plan.
• Customizing and preparing country- and site-specific agreements and organizing their translations.
• Tracking the status of site agreement and budget negotiation.

They are a company that cares for their staff, clients, partners and the quality of their work. A dynamic, global company founded in 1995, they bring together more than 3000 driven, dedicated and passionate individuals, working on the front line of medical science, changing lives, and bringing new medicines to those who need them.

• Accountable for study level tracking as assigned by the Clinical Project Manager.
• Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel.
• Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.

Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients.

• Develop external stakeholder engagement strategy.
• Strengthen medical and scientific relationships.
• Conduct timely medical initiatives.

Pfizer is dedicated to improving healthcare and transforming lives through innovative therapies. As a global company, they foster a culture of individual ownership and are committed to making the world a healthier place.

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of clinical studies.
• Develop study related clinical documents and generate potential site list from key stakeholders.
• Manage processes for investigational product including drug accountability and reconciliation.

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the speed, cost and success rate of bringing therapies to patients. They focus on Oncology and Rare Disease, providing deep scientific knowledge.