Clinical Trial Manager (Advanced Clinical)

Clinical Research Universe Featured Jobs

Posted: June 13, 2017

Job ID: 171

Job Summary

Term: Contract
Job Roles: Trial/Study Management
Therapeutic Experience: Oncology
Required Education: BA/BS in related field
Required Experience: 4+ years

Job Description

Home based support for liquid tumor studies/programs.
- in-house study management experience is required as is Oncology experience
- experience managing all the moving parts of a trial or multiple trials

• Manage project timelines and vendor performance to meet departmental and corporate goals
• Manage study budget and payment process for all clinical trial vendors including investigative sites
• Monitor and track clinical trial progress and provide status update reports
• Manage all clinical trial vendors (e.g., IVRS, central labs, and IRB)
• Responsible for selection of CRO study staff and coordinating training including documentation
• Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
• Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
• Lead the review of clinical data at the CRF, data listing, and report table levels
• Represent Clinical Operations at the Project Team level for individual studies, as appropriate
• Partner with other research and development groups to achieve deliverables
• Participate in Site Initiation Visits (SIVs) as required
• Co-Monitoring of regional sites for adherence to protocol and GCP as required
• Travel as required to carry out responsibilities
• Identify and escalate site, vendor and study related issues to supervisor, as appropriate
• Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
• Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals Perform other duties as assigned
Qualifications
• Ability to work within a team, including leadership skills
• Ability to organize and prioritize multiple tasks
• Excellent communication and interpersonal skills
• Attention to detail, organization, and problem-solving skills
• Computer literate
• Knowledge of FDA regulatory requirements and medical practice/techniques and terminology
• 25% travel required
Experience and Education Requirements:
• BA/BS in related field
• Minimum 8 years clinical drug development experience
• Experience in personnel management
• Experience in managing oncology clinical trials (international preferred)

- should be comfortable traveling to the Bay Area for occasional team meetings

To apply:
Mohammad Ouranos| Senior Clinical Recruiter
P 858-732-9110
mouranos@advancedclinical.com

Clinical Team Manager (PRA)

Clinical Research Universe Featured Jobs

Posted: June 13, 2017

Job ID: 170

Job Summary

Term: Full-Time
Job Roles: Trial/Study Management
Required Education: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (ie, registered nurse); or equivalent work experience required
Required Experience: 4+ years

Job Description

As a Clinical Trial Manager (CTM), you have a wide range of responsibilities. We’re including a few of the big ones. Primarily, you will work to achieve the most successful clinical trial possible. You will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. You will proactively identify, resolve/mitigate, and escalate risks or issues when necessary.

- English fluency (ability to read, write, speak); fluency in host country language required
- Experience in managing all trial components (start-up to database lock) preferred
- Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives preferred

Click here to apply: https://uscareers-prahs.icims.com/jobs/40511/clinical-team-manager---all...

Associate Manager, Clinical Documentation (Aerotek)

Clinical Research Universe Featured Jobs

Posted: March 24, 2017

Job ID: 170

Job Summary

Term: Full-Time
Job Roles: Trial/Study Management
:
Required Experience: 4+ years

Job Description

Requirements: 5+ years of experience in clinical research. TMF maintenance is very important. They are ideally seeking a candidate who has worked on the TMF through the submission process. This person will be managing 2 internal employees as well as managing the TMF vendor.

If interested, please contact Morgan McCormick (mmccormi@aerotek.com)

Clinical Trial Manager (Planet Pharma)

Clinical Research Universe Featured Jobs

Posted: October 3, 2016

Job ID: 167

Job Summary

Term: Contract
Job Roles: Trial/Study Management
:
Required Experience: 4+ years

Job Description

Responsible for supporting the Senior Clinical Trial Manager/operational study lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget).

Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance).

Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.

Responsible for monitoring assigned aspects of the study operational plan.

Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation
.
Please contact:
Dan Boersma
dboersma@planet-pharma.com

Sr. Clinical Project Manager (Real Life Sciences)

Clinical Research Universe Featured Jobs

Posted: October 3, 2016

Job ID: 166

Job Summary

Term: Full-Time
Job Roles: Trial/Study Management, Project Management
:
Required Experience: 4+ years

Job Description

Below are the relevant details of the position for you to review, please pass along an updated resume and time your available to go over details to see if it's going to be a good fit with your background.
Responsible and accountable for several clinical trials.
Facilitate investigational site budget negotiations.
Manages each project within agreed upon timelines.
Provides regular updates to the staff, Sponsor, vendors and contract staff concerning status and progress of the trial.
Facilitate protocol and related document development.
Responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring tools, monitoring plans, close-out plans.
Responsible for ensuring the trial is “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). Ensures that any audit observations are addressed appropriately and in a timely manner.
Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
Assist with training and supervising junior level CRAs.
Best Regards,

Rebecca Brown

Real Life Sciences
Desk Hub, 2159 India Street, Suite 200, San Diego, CA, 92101, United States
------------------------------------------------
T: +1 619 881 0004
E: r.brown@realstaffing.com

Associate Director/Director (Aerotek)

Clinical Research Universe Featured Jobs

Posted: October 3, 2016

Job ID: 165

Job Summary

Term: Full-Time
Job Roles: Trial/Study Management, Project Management
:
Required Experience: 4+ years

Job Description

Title: Associate Director/Director (depending on experience)
Company: Small Biotech
Location: San Diego, CA (must work in the office)
Target Salary: TBD
Travel: Very limited
Requirements: 8+ years of experience in clinical research. Will look at candidates at the Sr. Project/Trial Management level who are ready to take the next step. Must have experience working on EU trials. Ideally candidates will have experience at both a CRO and a small sponsor company. Must have experience with Phases I-IV and have the ability to lead a team.

Please contact:
Morgan McCormick
SR. ACCOUNT RECRUITING MANAGER
RECRUITER LEAD
CLINICAL DIVISION
(858) 609-2019 Phone

Clinical Study Manager (Advanced Clinical)

Clinical Research Universe Featured Jobs

Posted: July 30, 2016

Job ID: 164

Job Summary

Term: Full-Time
Job Roles: Trial/Study Management
Therapeutic Experience: Oncology
Required Education: Bachelor’s Degree required (oncology experience preferred).
Required Experience: 4+ years
Compensation: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.

Job Description

Sponsor is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.

Every member of our team plays a significant role in our success. Sponsor hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.

Function/Scope:

The Clinical Study Manager will be responsible for the conduct of clinical studies and data collection and review, monitoring adherence to protocols, and all activities related to study completion. The Clinical Study Manager will interact internally and externally with members of cross functional study team, and, externally with service providers, investigational site personnel, and others involved in the conduct of the business.

Duties and Responsibilities Include But Are Not Limited To:

- Provides management of clinical research studies across all functional areas of the drug development process.
- Oversees and coordinates the operational aspects of new and ongoing clinical studies to ensure corporate goals of time, cost, and quality expectations are met.
- Assures that clinical studies are compliant with ICH/GCP.
- Works primarily as a member of the project team and individually as tasks dictate.
- Supervises Clinical Research Associates (CRAs) as needed – provides guidance and training.
- Works within clinical development and other functional areas to develop protocols, CRFs, ICFs, and other study related documents.
- Oversees preparation of RFP’s and prepares bid templates to facilitate selection of the CRO’s/vendors.
- Collaborates with counsel to negotiate and draft research contracts and agreements with CRO’s/vendors and clinical study sites, as needed.
- Prepares the project plan/timelines and monitors against project progress; ensures project activity compliance with plan. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, budgets, etc. Takes corrective action where necessary.
- Develops and maintains standard operating procedures (SOPs) for Clinical Development that facilitates the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards.
- Liaises with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and -CRO/vendor audits are completed.
- Performs study risk management and implements mitigations.
- Performs other duties as required.

Desired Knowledge and Abilities:

- Must have a demonstrated track record of effective clinical conduct of clinical studies.
- Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to:
- Site selection
- Study initiation procedures.
- Clinical monitoring functions.
- Drug safety and regulatory affairs issues.
- Data flow from sites to data processing, review, and resolution.
- Analysis and report generation.
- FDA regulatory requirements (i.e. GCPs, CFRs, etc.). Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
- Effective communication and interpersonal skills.
- Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
- Must be able to travel up to 20% of time on average, may be higher in accordance with company and/or project requirements.
- Computer skills should include proficiency with Microsoft Office suite of software.

Education & Experience:

Bachelor’s Degree required (oncology experience preferred).
Minimum 8 years’ relevant industry experience in clinical/medical research, nursing or pharmaceuticals/devices.
Minimum 5+ years of prior clinical research experience.

If interested, please email your resume/CV to mouranos@advancedclinical.com

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical

Clinical Research Associate

Adecco Medical & Science

Posted: June 29, 2016

Job ID: 162

Job Summary

Term: Full-Time
Job Roles: Clinical Trial Monitoring, Trial/Study Management, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC)
Therapeutic Experience: Oncology
Required Education: Bachelor's
Required Experience: 2 years
Compensation: $80-100,000 DOE

Job Description

A Clinical Research Associate (CRA) job in San Diego, CA needs to be filled immediately by Adecco Medical & Science. This is a direct hire opportunity. In this position you will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures. Additionally, you'll be responsible for performing the clinical monitoring aspect of designated projects in accordance with applicable SOPs; performing clinical on-site monitoring activities. You will also be performing qualification, initiation, monitoring and termination visits of investigational sites, writing visit reports and completing all follow up actions in accordance with ICH GCP guidelines.This position is office based.

Clinical Research Associate job responsibilities:
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies, as needed.
• Participates in investigator site selection.
• Assists in coordinating activities for the conduct of clinical studies and interactions with CROs and other outside vendors.
• Performs protocol specific as well as GCP training for site personnel
• Continuously evaluates site performance and performs additional site training if needed
• Maintains all relevant site communications and both trial and site master files.
• Communicates regularly with sites and is aware of the activities of assigned clinical sites.
• Conducts and coordinates all activities, including report writing, associated with initiation, interim monitoring, study close out and audit visits as assigned.
• Communicates with internal departments as needed, including attending required meetings and following-up on action items.
• Assists in development of departmental processes, SOPs and personnel training programs.
• Verifies study data and facilitates the resolution of data queries and requests from Data Management.

Requirements:
• BS or RN degree required in a scientific or related field.
• Minimum 1-2 years of CRA experience within oncology is REQUIRED.
• Proven clinical monitoring skills required.
• Demonstrated understanding of medical terminology.
• Ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures.
• Computer skills required-must be proficient in Word, Excel, and PowerPoint.
• Excellent communication skills, ability to communicate effectively with all levels at the clinical sites and good people skills critical.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Flexibility; ability to travel up to 50-60%+.

If you are interested in this Clinical Research Associate (CRA) job in San Diego, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to melody.lam@adeccona.com

Streamline Over-reporting to IRBs

ACRP Training and Development is hosting a live webinar on how to streamline over-reporting to IRBs.

IRBs are over-burdened with reports not required by federal regulation. Study sites are often confused about reporting requirements and err on the side of "caution" by over-reporting.

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