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Senior Clinical Data Manager

extra holidays - fully flexible

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Australia

Offer summary

Qualifications:

Bachelor’s degree in life sciences or equivalent, 7 years as a CDM in CRO or Pharma, Formal ICH GCP training required, Knowledge of regulatory requirements.

Key responsabilities:

Develop study-related documents
Lead the Data management team

Avance Clinical Biotech: Biology + Technology Scaleup http://www.avancecro.com/

201 - 500 Employees

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Job description

Who are we?

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

The Role

The Clinical Data Manager I (CDM I) performs activities associated with the Data Cleaning activities of Clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Core Responsibilities

Autonomously Develop study-related documents or plans.
Lead the Data management team as the Lead CDM including development of Data Management Plan, eCRF completion Guidelines, Data Edit Checks Document, etc. Perform all activities (Start Up, Conduct and Closeout activities as per the SOPs Including the MedDRA/WHODD coding and/or review).
Develop effective relationships for assigned Sponsors to successfully manage sponsor grievances and drive strategic partnerships.
Raise data queries in the EDC where discrepancies are identified and work with CRA/site staff to ensure timely and accurate resolution.
Ensure accurate and timely filing as per SOP requirements.
Maintain effective communication across the study team to proactively manage on-going study expectations and issues.
Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.
Departmental Responsibilities
Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Data Management Team meetings.
Maintain effective communication with other members of the department.
Proactively identify risks related to departmental service provision and assist in their mitigation and resolution.
Participate in internal Quality Assurance activities as required, including responding to internal audit findings.

Organisational Responsibilities

Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike.
Commit to Avance Clinical training programs.
Adhere to Avance quality systems.
All staff are required to take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct.
The accountabilities as specified above may be altered in accordance with the changing requirements of the position.

Qualifications, Skills And Experience

Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field or appropriate industry experience.
Previous experience as a CDM in a Contract Research Organisation (CRO) or Pharma company for at least 7 years.
Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
Clear understanding of the requirement to adhere strictly to client confidentiality.
Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
Demonstrated ability to take initiative in problem solving and in exercising good judgment.
Ability to work under pressure in a multi-disciplinary team environment.
Willingness to work in, and be supportive of, a positive and dynamic team culture.

What we offer