Clinical Trial Project Manager Jobs

Coordinate and lead study team meetings and update Clinical Operations management on timelines and progress toward milestones.

Participate in selection and management / oversight of external vendors; develop vendor specifications; review vendor reports, budgets and forecasts, and metrics.

Independent study management of phase 1 and 2 studies at sponsor company or a CRO

Strong oral and written communication skills

Ability to work remotely and independently under general direction in a fast-paced and dynamic environment

Coordinate activities and provide oversight of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.

Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.

May be assigned to oversight and management of cross study/department initiatives and/or vendors.

Will assist in oversight and management of CROs, consultants and vendors.

Ensures assigned studies adhere to all applicable regulations and requirements.

Experience in phase I-III clinical studies. Global experience a plus.

Ability to work effectively in a team setting, remote teams, and fast paced environment.

Coordinates a multitude of CTM tactical and project management activities throughout the clinical trial lifecycle including forecasting/planning.

Management/tracking of global drug shipments; and Investigational Medicinal Product (IMP) accountability/ disposition.

NOTE: Can be fully remote but must be willing to come onsite the first 2 weeks for training.

Contract position: 1 year to start with potential for extension or conversion.

Note: 30-40 hours per week.

Implementation/oversight of IVRS/IWRS systems for drug supply.

• Experience in project management practices

• Possesses working knowledge of research objectives, protocol design, and data collection standards

• Experience with clinical operations systems including EDC, CTMS, and eTMF

3 years project management experience

Responsible for the management and overall coordination, status reporting and stability of a variety of enterprise-wide projects.

Technical and/or R&D background with CMC experience strongly preferred

As a Project Manager you will:

Provides facilitation of meeting logistics, including scheduling, agendas and minutes.

May work closely with internal departments and outside vendors to ensure project completion.

3-5 years of clinical operations experience with at least two years of clinical project management experience.

Clinical Research Certification (SOCRA or ACRP) and/or project management certification (PMP) is desired.

Required Knowledge, Skills and Abilities:

Experience at a sponsor or CRO within Medical Devices is strongly preferred.

Proficient in Microsoft Office Suite and working knowledge of eTMF, CTMS, and EDC systems.

Experience developing and writing clinical study protocols and reports is a plus.

·Experience of Study Management within a pharmaceutical or clinical background

·Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management

o Manager would like to see candidates with Clinical Research experience.

·Understanding of multiple aspects within Study Management

Pricing and Contract Strategy Manager

o Looking for someone that has experience that has negotiating contact language and budgets with clinical contracts.

3 years of relevant clinical research and project management experience with a CRO, pharmaceutical, biotechnology / device company

Strong project management skills including client management, fiscal / contract management, and quality management

Perform contract and financial management activities for assigned trials and serve as central point of contact with sponsor for project updates

Oversee all aspects of clinical research projects to assure applicable regulations, standard operating procedures, and sponsor requirements are met.

Bachelor’s Degree or equivalent experience

Good knowledge of FDA guidelines and review processes, IND and NDA processes, and GCPs

CRO oversight and study management

·Oversight of CRO including revieing monitoring reports, data management metrics, conducting oversight or co-monitoring visit etc.

·Expected educational qualifications: MSc or BSc

·Experience with digital clinical trial systems such as eTMF, EDC, IRT etc

·Knowledge within (radio/bio) pharmaceuticals and/or oncology will be considered as an advantage

·Excellent communication skills (verbal, written and interpersonal) and negotiation skills

· Maintains compliance in assigned region or project for performance, deliverables, and associated KPI’s.

· Ensures alignment of clinical activities to budget, including identification of out of scope activities.

· May participate in business development proposals, defense meetings and proposal development.

1 - 3 years’ clinical operations / management experience from sponsor

Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills

Manages outsourced clinical operations functions, which may include contracted investigational supply, data management biostatistics, etc.

Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed

Minimum BS/BA from an undergraduate program or equivalent experience

Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment

Executes a project plan including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting)

Works with CRAs, Data Management, CTCs and Document Control Specialist to create and manage study related documents

Works closely with data management to ensure quality of clinical trial data

Manages planning and communication with cross-functional teams to ensure proper execution and conduct of the trial

Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues

Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Knowledge of project management methodologies including scope management, resource management, schedule management, stakeholder management and communication, budget management, and risk management.

2+ years of project management experience

BS/BA in science, engineering or business administration or equivalent combination of education and work experience

Experience organizing and presenting key project metrics, progress, risks, and dashboards for Project Reviews.

Strong presentation capabilities including ability to develop and deliver formal communications.

Software skills: Excel, MS Project, Word, PowerPoint, SharePoint, One Drive, Outlook and Smartsheet

Bachelor’s degree in a scientific/medical/pharmaceutical discipline (other commensurate qualifications and/or related experience in industry considered if equivalent)

Working experience with global clinical transparency regulations, eg EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation 536/2014

At least 3 years working in a Clinical Development and/or regulatory affairs environment

Sound understanding of the drug development process

Awareness of the Clinical Trial Application process and/or the contents of the clinical modules of the Marketing Authorization Application

Awareness of privacy regulations, eg GDPR

Advanced skills and through knowledge in regard to all clinical operations and site management activities

Advanced skills in Project Management, particularly in regard to management of schedule, budget, communication, resources and quality

Project Management – Responsible for overall execution of clinical trials within designated study budgets, timelines and quality standards.

Study Management Tools – Ensures that study teams and clinical sites have the appropriate study management tools to execute the study.

Trial Master File - Ensures that the study regulatory files are collected and inventoried and filed as per SOP requirements.

Ancillary Supplies – Ensures study materials and supplies are appropriately managed in regards to ordering, tracking and within budgetary considerations.

Have knowledge and skills to use SAM2 and Sage.

Bachelor’s Management or the Agriculture/Horticulture field

Costa Farms offers competitive wages and benefits, including:

Ability to capture requirements and identify gaps.

Teamwork and leadership skills, proactive attitude

Working knowledge of MS Office and MS Teams

Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management

Solid understanding of clinical operations and study management processes, along with experience in various phases of development and therapy areas

Demonstrated Project Management skills (e.g., leading delivery team)

Keeps own knowledge of best practices and new relevant developments up to date.

Excellent knowledge of spoken and written English

Strong communication skills with the ability to build positive relationships, including vendor leadership skills

Bachelor degree in related discipline, preferably in life science, or equivalent qualification.

Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields

Good knowledge of international guidelines ICH- GCP as well as relevant local regulations.

Excellent verbal and written communication skills.

Excellent knowledge of spoken and written English  

Excellent knowledge of spoken and written English

•Recommends and implements innovative processes to improve and impact clinical trial management and deliverables.

•Demonstrated successful setup and management of CROs and associated vendors (e.g., IRT, central laboratory, imaging, etc.).

•Thorough knowledge of CFR and ICH/GCP requirements.

Clinical Trial Manager/Senior Clinical Trial Manager

•Proactively manages and leads a cross-functional study team, including risk analysis and mitigation.

•Helps develop and manage clinical budgets and contracts plans for clinical trials.

Previous managerial experience directly managing people and/or experience in leading teams, projects, programs or directing the allocation of resources

High school diploma/GED and 12 years of Manufacturing & Operations experience OR

Associate’s degree and 10 years of Manufacturing & Operations experience OR

Bachelor’s degree and 5 years of Manufacturing & Operations experience OR

Master’s degree and 3 years of Manufacturing & Operations experience OR

Solid knowledge of downstream, as well as a general knowledge of the associated analytical and buffer preparation techniques