Contract - Sr Clinical Trial Manager (CTM)

Cytokinetics, Inc.; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Clinical Trial Manager to oversee and support clinical trials. This role requires extensive experience in clinical operations, regulatory compliance, and effective communication skills. The successful candidate will be pivotal in managing trial activities, ensuring timely and budget-compliant progression of clinical studies to improve patient lives.

Qualifications

• 8+ years’ experience as a CRA or CRA/CTM.
• Demonstrated thorough understanding of FDA regulations and GCP.
• Ability to travel approximately 20% time.

Responsibilities

• Manage activities for multiple clinical studies.
• Ensure compliance with FDA regulations and ICH guidelines.
• Lead Phase II or Phase III clinical programs.

Skills

Strong communication skills

Problem-solving skills

Attention to detail

Time management skills

Education

BA/BS in science-related field

Tools

Microsoft applications

Job description

Contract - Sr Clinical Trial Manager (CTM) page is loaded

Contract - Sr Clinical Trial Manager (CTM)

Apply locations South San Francisco, California time type Full time posted on Posted 30+ Days Ago job requisition id R52

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Job Purpose

The Senior Clinical Trials Manager will provide key oversight, guidance, and support for the operation and execution of clinical trials for Cytokinetics clinical program.

Responsibilities

• Manage various activities associated with multiple clinical studies in accordance with designated project assignments

• Use thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct

• Lead significant Phase II or Phase III program with a focus on clinical operations

• Design study related documents (or sections therein) including but not limited to: clinical protocols, case report forms, site study manuals, project tools, monitoring plans, tracking tools, informed consent forms

• Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed

• Lead cross-functional study management team meetings, study operations team meetings, and teleconferences with study vendors

• Manage study-specific CROs and vendors and contract CTMs and CRAs as appropriate

• Perform independent monitoring of sites as required by needs of project

• Attend scientific meetings as a representative of Cytokinetics clinical operations team

• Provide critical insight regarding evaluation and selection of CROs and other outside vendors

• Coordinate efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other Cytokinetics departments as appropriate

• Coordinate efforts in all stages of study conduct (enrollment, follow-up, close-out) and oversees clinical operations team and CRO/vendors to ensure the study achieves its goals on time and within budget

• Collaborate with Finance, Clinical Outsourcing Manager, and line manager on vendor and study site budget tracking and compliance

• Use well-developed problem-solving skills to address needs of program and provides guidance to other lower level personnel

• Participate in interviews of Clinical Operations candidates (FTEs and contractors) and provides feedback to hiring manager

Qualifications

• BA/BS in science-related field with 8+ years’ work experience as a CRA or CRA/CTM combination of relevant related work experience

• Strong communication skills (verbal and written)

• Well-developed strong problem-solving skills

• Demonstrated thorough understanding of FDA regulations and GCP

• Exceptional interpersonal skills with demonstrated successful team participation

• Demonstrated skill in managing multiple tasks simultaneously, with attention to detail

• Ability to work under pressure and deal with time demands; good time management skills

• Ability to appropriately assess prioritization of assigned activities

• Ability to proactively identify issues and address with solutions-oriented approach

• Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc.

• Ability to travel important as the position could require approximately 20% time spent in business travel

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $105.00 - $125.00 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [e-mail]

Please visit our website at:www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

About Us

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.