Description:
Location: United States - Home-based

Schedule: Full-Time, Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Senior Clinical Project Manager to join one of our clients, a multinational pharmaceutical company.

CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.

The ideal candidate will have proficient experience within complex clinical trials, such as Oncology, Respiratory, Ophthalmology, or Rare Diseases, as well as be able to work cross-functionally to ensure quality, budget, and timelines are met. You will be the central point of communication for all clinical trial-related activities to assure trials are conducted on time and budget while being fully GCP, ICH, and SOP compliant.

Main Job Tasks and Responsibilities:

• Accountable for study execution, tracking, and management of study delivery, including oversight of vendor and CRO activity
• Maintains the global study budget, ensuring cost-effectiveness and addressing and escalating issues as appropriate
• Ensures set up and maintenance of all systems in order to plan and implement the study and track progress
• Develops recruitment plan, manages risk, monitors progress, and implements contingencies as required
• Ensures efficient streamlined processes are in place to deliver study to plan and ensure the safety of patients and completeness/integrity of data
• Ensures for timely delivery of scientifically and operationally robust study documents
• Ensures development, review, finalization and delivery of high-quality key clinical study documents in order to meet study timelines. This will include the protocol, Investigator Brochure, Clinical Trial Agreements and Informed Consent Forms.
• Creation, revision and/or maintenance of regulatory documents that support investigational (IND and IDE) and marketing application (ANDA, NDA, 510(k), PMA, etc.) filings
• Ensures accurate maintenance and archiving of study records
• Ensures monitoring and site personnel are familiar with all study-specific processes, procedures, and systems and that training is adequately documented
• Ensures continuous direct contact with in-country personnel to provide ongoing operational support
• Accountable for study-related communications and for resolution or escalation of operational issues

Education and Experience:

• Educated to degree level (biological sciences, pharmacy, or other health-related discipline preferred) or relevant experience in a medical/nursing field
• Extensive experience as a Clinical Project Manager
• Preferably experience with complex therapeutic areas
• Experience in monitoring clinical trials to ICH/GCP
• Experience with Global Studies (not just in the US)

Skills:

• Excellent interpersonal, verbal, and written communication skills (in English)
• Ability to motivate both individually and collectively
• Excellent problem-solving capability through early identification
• Excellent computer literacy
• Travel may be required
• Excellent computer literacy
• Flexibility to deal with changes/demands from the sponsor

The Benefits of Working for TalentSource in the US:

• Full health insurance benefits that include health, dental, and vision
• 401K Plan with 5% company match after satisfying 90 days of employment
• Short term and long term disability insurance
• Life insurance
• Paid vacation, sick leave, and holidays
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @

https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Senior Clinical Project Manager, Clinical Project Manager, Clinical Trials, Clinical Research, Pharma, Pharmaceutical, Oncology, Rare Disease, Medical Device, Respiratory, Ophthalmology, Regulatory, IRB submissions, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated

Skills: Clinical Project Manager Location: United States Share:

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