Precision Medicine Group
More roles at Precision Medicine GroupClinical Trial Manager
Remote work allowed only within certain countries or regions.
Employer listed it 4 days ago · Added 4 days ago
First listed 4 days ago and still open.
Salary
Not stated
Location
Timezone
APAC
Contract
Full-time
Experience
Senior
Category
Other
The employer did not publish a salary, and we have too few comparable roles to estimate one.
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
- Contract
- Not mentioned in the advert
- Experience asked for
- Not mentioned in the advert
- Pay
- Not mentioned in the advert
Remote flexibility
Region Restricted
Remote work is allowed, but only for candidates based in Australia, Singapore, South Korea.
What the employer says
- Source listing states candidate location: "Remote, Australia; Remote, Singapore; Remote, South Korea, Remote (Australia), Remote (Singapore), Remote (South Korea)"
- Job description states: "authorized to work in the country of employment without"
What Nomaders makes of it
- Timezone overlap with the listed area is often expected
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
Before you apply
Experience: employer states
Written as a requirement
- “Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.”
Questions worth asking: Nomaders interpretation
- No pay is stated. Ask for the salary range before investing time in interviews.
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
About the role
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are hiring for a Clinical Trial Manager.
Position Summary:
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:
Primary clinical point of contact with the client
Collaborate with PM on monthly invoicing and variance management of clinical budget
Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
Generate potential site list from key stakeholders and drive site feasibility process
Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
Develop and finalize the country recruitment/retention strategy
Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
Support in planning and conducting investigator meetings
Review and/or approve of IP release packages
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
Responsible for eTMF implementation and management
Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
Work closely with PM for project-specific resourcing issues
Requirements
The employer hasn't listed requirements separately, they're described in the role summary above and on the original listing.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, region restricted, matches where you plan to live and work.
- 2Tailor your CV to the role at Precision Medicine Group, mentioning your remote working experience and working hours (APAC).
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 5d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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