Precision For Medicine

Strategy

• Drive and support the operational strategy considerations for RFPs, bid defense meetings (BDMs).
• Represent Precision operations at pre-award meetings.
• Lead specific projects enabling Precision for Medicine to stay at the forefront of innovation.
• Collaborate with medical, operational, business development teams on operational considerations.
• Ensure proposals reflect robust strategic, operational, scientific, medical and clinical development planning.
• Create and refine study budgets in partnership with other functional leadership.
• Mentor and train Operational Strategy colleagues and Precision colleagues.

Operational Strategy Director – Oncology

Research Analyst

• Monitor and own the progress of clinical studies at investigative sites
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.)

Clinical Research Associate I/II

Compliance

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF.
• May support the clinical team performing Pre-Study Site Visits.

Regulatory and Start Up Specialist

• You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Clinical Research Associate II

• Monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.)

• Monitor and own the progress of clinical studies at sites
• Ensure studies are conducted per protocol and standards
• Coordinate activities required to set up and monitor a study

• Monitor and own the progress of clinical studies at investigative sites• Ensure clinical studies are conducted, recorded, and reported per protocol• Coordinate necessary activities required to set up and monitor a study• Handle appropriately sized clinical trials and support larger trials• Interact directly with clients and participate in proposal activities• Train and mentor junior staff members

Senior Clinical Research Associate

Project Manager

• You will independently lead clinical projects in accordance with the study budget and scope of work.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

Senior Project Manager, Clinical Trials

• Independently lead clinical projects in accordance with the study budget and scope of work
• Use strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

• Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology.
• Do you take a consultative approach to trial management, proving to be a valuable partner in trial operational delivery?
• In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology (or Rare Diseases or CNS).
• Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.
• Involved in all study stages, including proposal strategy, development, costing, and bid defence, and seeing studies through the full cycle to completion, managing the client relationship, project team and budget and timelines throughout.
• You will work in a cross-functional team with both internal and external stakeholders, driving quality and coordinating the study team.

Senior Project Manager – Clinical Trials

• You will independently lead clinical projects in accordance with the study budget and scope of work.
• You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives.
• You may be called upon to run international trials as well.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

• Independently lead clinical projects in accordance with the study budget and scope of work
• Use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

• You will independently lead clinical projects in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. You may be called upon to run international trials as well.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

Medical Director

• The Medical Director serves as the project physician and provides medical and scientific expertise to project teams.
• Ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety.
• Participate in the strategic planning and execution of critical development programs for various clients in Oncology/Haematology.
• Collaborate with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
• Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; support or participate in bid defense meetings.
• Write or edit scientific content of deliverables within budget and timelines.
• Collaborate with Regulatory Affairs on regulatory product landscape and strategies as part of overall drug development strategy.
• Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts).

• Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
• Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings.
• Write or edit scientific content of deliverables within budget and timelines.
• Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy.
• Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts).
• Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications.
• Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed.
• Serve as a medical resource for study sites, the project team and clients.
• Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
• Assume responsibility for medical and safety monitoring on assigned projects.
• Participate in feasibility discussions relating to specific project proposals.
• Develop training modules and provide training concentrating on disease states.
• Participate in process improvement activities.
• Collaborate with Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally.